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Monthly Update Report for Trials Started in May 2026


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1: Summary data from new trials identified for Leukemia and Lymphoma.


Overview

Number of Trials: 29

These 29 trials investigate treatments for hematologic malignancies (primarily leukemias and lymphomas) and related conditions. Common themes include CAR-T cell therapies, bispecific antibodies, kinase inhibitors, and combination regimens. Several trials target specific genetic mutations (e.g., KMT2A, IDH1, BRAF V600E, BCR-ABL1). Many studies focus on relapsed/refractory disease, post-transplant settings, or frontline therapy in older/unfit patients. Interventions range from novel targeted agents to established chemotherapy backbones, with emphasis on improving efficacy, reducing toxicity, and preventing complications like GVHD and infections.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years (most trials)
  • Confirmed diagnosis of specific hematologic malignancy (AML, ALL, CLL, lymphoma)
  • Measurable or assessable disease
  • ECOG/Karnofsky performance status ≤2 (or ≥50-60%)
  • Adequate organ function (liver, kidney, cardiac, pulmonary)
  • Recovery from prior therapy toxicities to ≤Grade 1
  • Negative pregnancy test for females of childbearing potential
  • Agreement to use effective contraception
  • Ability to provide informed consent

Common Exclusion

  • Active uncontrolled infection
  • CNS involvement by malignancy (active or symptomatic)
  • Pregnant or breastfeeding
  • HIV with detectable viral load or CD4 <200 (unless controlled)
  • Active hepatitis B or C (unless undetectable viral load)
  • Prior allogeneic transplant within specified timeframe or active GVHD
  • Concurrent malignancy interfering with study assessment
  • Severe cardiac disease (NYHA Class III/IV, recent MI, LVEF <40-50%)
  • Psychiatric or substance abuse disorders impairing compliance
  • Hypersensitivity to study drugs

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT06965114

A Phase 1 Study of Combination Tovorafenib (DAY101) and Rituximab Treatment in Relapsed or Refractory Classical Hairy Cell Leukemia and Phase 2 Randomized Study Comparing Tovorafenib (DAY101) and Rituximab With Cladribine and Rituximab for Front-Line Treatment of Classical Hairy Cell Leukemia Genomic-based

Organization/Sponsor: National Cancer Institute (NCI)


Example patient: A 52-year-old treatment-naïve man with classical hairy cell leukemia confirmed BRAF V600E mutation positive, presenting with neutropenia (ANC 800/mcL), thrombocytopenia (platelets 85,000/mcL), splenomegaly, and ECOG performance status 1, with adequate organ function and no history of CNS involvement.

Phase 1, Phase 2

Interventions

  • Drug: Tovorafenib
    Summary: Tovorafenib is an orally available Type II pan-RAF kinase inhibitor targeting wild-type and mutant A-Raf, B-Raf, and C-Raf, blocking RAF/MEK/ERK signaling to inhibit tumor cell proliferation and survival; FDA-approved for pediatric low-grade glioma with BRAF alterations (FDA label, NCI Thesaurus).
  • Drug: Rituximab
    Summary: Rituximab is a chimeric anti-CD20 monoclonal antibody that depletes B cells via complement-dependent and antibody-dependent cellular cytotoxicity, indicated for CD20-positive B-cell malignancies including lymphomas and chronic lymphocytic leukemia (FDA label, NCI Thesaurus).
  • Drug: Cladribine
    Summary: Cladribine is a chlorinated purine nucleoside analog antimetabolite that incorporates into DNA causing strand breaks, NAD/ATP depletion, and apoptosis; indicated for active hairy cell leukemia with cytopenias or symptoms (FDA label, NCI Thesaurus).
  • Procedure: Computed Tomography
    Summary: CT scanning uses X-rays and computer reconstruction to create cross-sectional images for monitoring tumor progression and assessing treatment effectiveness in cancer trials (NCI Thesaurus).
  • Procedure: Bone Marrow Biopsy
    Summary: Bone marrow biopsy removes core tissue containing bone spicules and hematopoietic elements for microscopic diagnosis and evaluation of hematologic malignancies including leukemias and lymphomas (NCI Thesaurus).
  • Procedure: Bone Marrow Aspiration
    Summary: Bone marrow aspiration extracts immature hematopoietic elements and blood from marrow for evaluation of hematopoietic disorders, infectious diseases, and cytogenetic studies (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Biospecimen collection gathers tissue and fluid samples for testing, diagnostic, and research purposes to analyze genetic and molecular features in cancer (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed classical hairy cell leukemia with BRAF V600E mutation
  • Age 18 years or older
  • Indications for treatment: cytopenias, infections, symptomatic extramedullary disease, or constitutional symptoms
  • Phase 1: Prior purine analog therapy unless contraindicated
  • Phase 2: Treatment-naïve for front-line cohort
  • ECOG performance status ≤2 or worse if due to HCL
  • Adequate organ function: bilirubin ≤1.5x ULN, AST/ALT ≤3x ULN, creatinine clearance ≥30 mL/min
  • Effective contraception during treatment and 12 months after last dose

Key Exclusion

  • CNS involvement with HCL
  • BRAF V600E mutation negative or variant HCL
  • Platelets <50,000/mcL
  • Current use of warfarin or direct oral anticoagulants
  • Unrecovered toxicities >grade 1 from prior therapy
  • Concurrent investigational agents or strong CYP2C8 inhibitors/inducers
  • Pregnancy, breastfeeding, or unwilling to use contraception
  • History of severe infusion reactions to rituximab or hypersensitivity to study drugs

NCT05974202

Augmenting Cognitive-behavioral Therapy With rTMS of the Medial Prefrontal and Anterior Cingulate Cortices for the Treatment of Cocaine Use Disorder

Organization/Sponsor: New York State Psychiatric Institute


Phase N/A

Interventions

  • Device: Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)
    Summary: Sham H7-coil rTMS is a placebo control that mimics active stimulation without delivering therapeutic magnetic fields to brain regions (Summary of Web Search).
  • Device: Active H7-coil repetitive transcranial magnetic stimulation (rTMS)
    Summary: Active H7-coil rTMS uses magnetic fields to stimulate medial prefrontal and anterior cingulate cortices, inducing neuroplastic changes to reduce cocaine use disorder symptoms (Summary of Web Search).

Key Inclusion

  • Age 22-65
  • DSM-5 criteria for current moderate/severe cocaine use disorder
  • Treatment-seeking
  • Used cocaine at least 9 days in past 28 days with weekly use
  • Agree to moderate alcohol consumption limits
  • Women must use contraception

Key Exclusion

  • Current moderate/severe major depressive episode, bipolar disorder, schizophrenia, or psychotic disorder
  • Hamilton Depression Rating Scale score >17
  • Current moderate/severe other substance use disorder except tobacco
  • Seizure history including epilepsy or withdrawal seizures
  • Metal implants or devices prohibiting MR scanning
  • Medications lowering seizure threshold
  • Cognitive disorder (MMSE <25)
  • Legally mandated to participate in treatment

NCT07548983

A Phase I Study to Evaluate the Safety of Ruxolitinib in Combination With Azacitidine Maintenance in Patients Undergoing Reduced Intensity Allogeneic Transplant for Acute Myeloid Leukemia (AML) Genomic-based

Organization/Sponsor: OHSU Knight Cancer Institute


Example patient: A 52-year-old man with newly diagnosed AML harboring FLT3-ITD mutation and adverse-risk cytogenetics achieved CR after induction chemotherapy but has persistent MRD by NGS, now planned for reduced-intensity allogeneic HSCT with an 8/8 matched unrelated 28-year-old donor.

Phase 1

Interventions

  • Drug: Ruxolitinib
    Summary: Ruxolitinib is a JAK1/JAK2 inhibitor that suppresses cytokine signaling and inflammation, used to prevent graft-versus-host disease and as maintenance therapy in AML transplant patients (FDA label, NCI Thesaurus).
  • Drug: Azacitidine
    Summary: Azacitidine is a nucleoside analogue that inhibits DNA methyltransferase, reactivating tumor suppressor genes and disrupting RNA function, used for maintenance therapy in AML post-transplant (FDA label, NCI Thesaurus).
  • Drug: Cyclophosphamide
    Summary: Cyclophosphamide is an alkylating agent that cross-links DNA to prevent replication, used post-transplant for graft-versus-host disease prophylaxis at 25 mg/kg on days +3 and +4 (FDA label, NCI Thesaurus).
  • Drug: Tacrolimus
    Summary: Tacrolimus is a calcineurin inhibitor that suppresses T-cell activation and interleukin-2 production, used to prevent graft-versus-host disease in allogeneic transplant recipients (FDA label, NCI Thesaurus).
  • Drug: Mycophenolate Mofetil
    Summary: Mycophenolate mofetil inhibits inosine monophosphate dehydrogenase, blocking purine synthesis and lymphocyte proliferation, used for graft-versus-host disease prophylaxis in transplant patients (FDA label, NCI Thesaurus).
  • Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
    Summary: Allogeneic hematopoietic stem cell transplantation replaces diseased marrow with donor stem cells, utilizing graft-versus-malignancy effect to eradicate AML and restore immune function (Web Search).
  • Procedure: Reduced-Intensity Transplant Conditioning Procedure
    Summary: Reduced-intensity conditioning uses lower-dose chemotherapy and radiation to prepare for transplant, minimizing toxicity while enabling donor cell engraftment and graft-versus-host disease prevention (NCI Thesaurus).
  • Procedure: Bone Marrow Biopsy
    Summary: Bone marrow biopsy removes core tissue with bone spicules and marrow for microscopic analysis to diagnose and monitor AML and evaluate treatment response (NCI Thesaurus).
  • Procedure: Bone Marrow Aspiration
    Summary: Bone marrow aspiration extracts immature hematopoietic cells and blood from marrow for evaluation of AML, cytogenetics, and minimal residual disease assessment (NCI Thesaurus).
  • Other: Biospecimen Collection
    Summary: Biospecimen collection gathers blood, tissue, and marrow samples for research, diagnostic testing, and molecular analysis to study AML mechanisms and treatment response (NCI Thesaurus).
  • Other: Survey Administration
    Summary: Survey administration collects self-reported patient data on experiences, symptoms, and quality of life to assess treatment impact and patient-reported outcomes (NCI Thesaurus).
  • Other: Electronic Health Record Review
    Summary: Electronic health record review involves analyzing patient data to assess treatment outcomes, adverse events, and clinical course during and after transplant (NCI Thesaurus).
  • Diagnostic Test: Echocardiography Test
    Summary: Echocardiography uses ultrasound to image the heart and monitor cardiac function, detecting chemotherapy-related cardiotoxicity in AML patients undergoing transplant (Web Search, NCI Thesaurus).
  • Diagnostic Test: Multigated Acquisition Scan
    Summary: MUGA scan uses radioactive tracer and gamma camera to measure left ventricular ejection fraction, monitoring cardiac function and chemotherapy-related cardiotoxicity (Web Search, NCI Thesaurus).

Key Inclusion

  • Age ≥18 years with AML in complete remission (CR or CRi) after induction
  • High risk for relapse based on cytogenetics, MRD by NGS, or ELN 2022 adverse risk
  • Planned reduced-intensity or non-myeloablative conditioning allogeneic HSCT with unrelated donor
  • Unrelated donor with 7/8 or 8/8 HLA match, age 18-35 years
  • Post-transplant cyclophosphamide/tacrolimus/MMF GVHD prophylaxis planned
  • Karnofsky performance status ≥50%
  • Day +30 chimerism ≥70% donor CD3+ cells and 100% donor CD33+ cells (Part B)
  • ANC ≥1,000/μL and platelets ≥50,000/μL without growth factor support (Part B)

Key Exclusion

  • Active CNS involvement with AML
  • Acute promyelocytic leukemia (APL)
  • Prior intolerance or treatment failure with ruxolitinib
  • Ejection fraction <40% or NYHA grade III/IV heart failure
  • History of stroke within 60 days or MI/PE within 6 months
  • Known HIV infection or active tuberculosis
  • Primary or secondary graft failure (Part B)
  • Active acute GVHD grade II or greater (Part B)

NCT07374315

A Family-based Intervention Approach to Address Weight Gain in Pediatric Leukemia Survivors

Organization/Sponsor: Washington University School of Medicine


Example patient: A 12-year-old English-speaking patient with B-cell ALL currently on maintenance chemotherapy, able to walk briskly for five minutes, with negative SCOFF screen and a participating caregiver, without developmental delays or mental illness.

Phase N/A

Interventions

  • Educational Platform: WashU Extended Learning Canvas
    Summary: Educational platform targeting pre-leukemic conditions and employing innovative immunotherapies including CAR-T cell treatments for aggressive T cell cancers using gene editing mechanisms (Summary of Web Search).
  • Device: FitBit Ace
    Summary: Wearable activity monitor measuring steps, heart rate, sleep quality, and fitness metrics to encourage physical activity and improve outcomes in pediatric cancer patients (NCI Thesaurus, Summary of Web Search).
  • Educational Resource: NIH Educational Resources
    Summary: Educational interventions targeting leukemia and lymphoma patients through innovative treatment approaches and educational support to improve patient outcomes (Summary of Web Search).
  • Behavioral: Modified Guided Self-Help Family Intervention
    Summary: Family-based counseling intervention providing psychological support and structured guidance to improve coping strategies and emotional well-being through self-help techniques for families dealing with leukemia or lymphoma (Summary of Web Search).

Key Inclusion

  • Diagnosis of ALL (T or B cell)
  • Receiving standard of care maintenance chemotherapy or within 6 months of concluding maintenance
  • Age 6 to 18 years at enrollment
  • Able to speak and understand English
  • Participating caregiver required
  • Able to perform exercise for at least five minutes
  • Patients 10 and older must have negative SCOFF screen for disordered eating

Key Exclusion

  • Severe developmental delay or intellectual disabilities (e.g., Trisomy 21, severe autism spectrum disorder)
  • Significant mental illness (active suicidal ideation, psychotic symptoms, manic/hypomanic episodes, severe substance use disorder)
  • SCOFF score of 2 or more for patients 10 and older

NCT07220993

Novel Unedited Allo Cell Therapy For High Risk T-Cell Malignancies Using CD7-Specific Car Expressed On T Cells (NEO-CRIMSON)

Organization/Sponsor: Baylor College of Medicine


Example patient: A 45-year-old patient with relapsed T-cell acute lymphoblastic leukemia 90 days post-allogeneic HSCT from a matched related donor, with 65% CD7-positive blasts, Karnofsky score of 70%, no active GVHD, and a suitable unrelated donor identified for second transplant.

Phase N/A

Interventions

  • Biological: CD7.CAR/28zeta T Cells
    Summary: Allogeneic CAR T cells engineered to target CD7 protein on T-cell leukemia and lymphoma cells using a chimeric antigen receptor with CD28 co-stimulatory domain to enhance T-cell activation and kill cancer cells (Source: Web Search).

Key Inclusion

  • Recurrent T-ALL, T-LL, or T-NHL relapsed post-allogeneic related donor HSCT
  • CD7-positive tumor (≥20% CD7+ blasts by flow cytometry or immunohistochemistry)
  • Age ≤75 years old
  • Suitable for allogeneic HSCT with suitable donor identified
  • Karnofsky or Lansky score ≥60%
  • ≥60 days post-allogeneic HSCT at time of treatment
  • Available partially-HLA matched allogeneic EBV-specific T cell line
  • Estimated GFR ≥50 mL/min

Key Exclusion

  • Active acute GVHD >Grade II or active chronic GVHD >mild global severity
  • Currently taking corticosteroids >0.5mg/kg prednisone equivalent
  • Received immunosuppressive treatment for GVHD within 28 days
  • Clinically significant infection or uncontrolled viral reactivation
  • CNS-3 disease or CNS abnormalities
  • LVEF <50% or LVSF <30%
  • Pregnant or lactating
  • Tumor location where enlargement could cause airway obstruction

NCT07559474

A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment

Organization/Sponsor: Incyte Corporation


Example patient: A 55-year-old patient with relapsed lymphoma and moderate hepatic impairment due to cirrhosis, BMI 28 kg/m2, stable disease status, no recent paracentesis or encephalopathy changes, and controlled diabetes with HbA1c of 7.5%.

Phase 1

Interventions

  • Drug: INCB123667
    Summary: An orally bioavailable CDK2 inhibitor that blocks CDK2/cyclin E1 activity, preventing retinoblastoma phosphorylation and G1/S cell cycle transition, leading to apoptosis and inhibition of tumor cell proliferation in cancers overexpressing CDK2 and CCNE1 (Source: NCI Thesaurus).

Key Inclusion

  • Aged 18 to 80 years
  • Moderate or severe hepatic impairment based on Child-Pugh score
  • Body mass index 18.0 to 43.0 kg/m2
  • Medical findings consistent with degree of hepatic dysfunction

Key Exclusion

  • Current functioning organ transplant or on transplant list
  • Tobacco use >10 cigarettes per day within 1 month
  • Change in disease status within 30 days deemed clinically significant
  • History of paracentesis within 2 months
  • New medication or dose increase for hepatic encephalopathy within 3 months
  • Unstable diabetes mellitus (HbA1c ≥10.0%)
  • Portal systemic shunt (except up to 3 with TIPS)
  • Esophageal banding within 3 months or GI bleeding treatment within 6 months

NCT07628634

Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors

Organization/Sponsor: University of California, Irvine


Example patient: A 55-year-old man with metastatic colorectal cancer, ECOG performance status 1, adequate organ function, life expectancy of 12 months, willing to follow a methionine-reduced diet while receiving standard chemotherapy.

Phase N/A

Interventions

  • Dietary Intervention: Methionine-Reduced Diet
    Summary: A diet limited in the amino acid methionine that inhibits cell cycle progression and induces apoptosis in transformed cells but not normal cells, inhibiting tumor growth in diverse cancer models (NCI Thesaurus).

Key Inclusion

  • Age 18 years or older
  • Metastatic, recurrent, or unresectable solid tumors
  • Life expectancy at least 3 months
  • ECOG performance status 0-2
  • Adequate organ function
  • Willing to comply with methionine-reduced diet
  • Able to receive systemic standard of care cancer therapy
  • For glioma: newly diagnosed grade 2-3 or recurrent all grades

Key Exclusion

  • Uncontrolled or symptomatic brain metastases
  • Active infections requiring systemic therapy
  • Recent myocardial infarction within 6 months or severe cardiovascular conditions
  • Severe liver disease or inherited metabolic disorders affecting amino acid metabolism
  • Major surgery within 4 weeks
  • Pregnant or breastfeeding
  • Severe malnutrition or significant nutritional deficiencies
  • Chronic kidney disease stage 3b or higher

NCT07567014

A Phase II Study of the Interferon Gamma Inhibitor Emapalumab for Prophylaxis of Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity Syndrome in Patients With Lymphoma and Multiple Myeloma Receiving Bispecific T-Cell Engagers

Organization/Sponsor: NYU Langone Health


Example patient: A 62-year-old man with diffuse large B-cell lymphoma relapsed after two lines of therapy, ECOG 1, adequate organ function, no active infections or CNS involvement, planned to receive epcoritamab bispecific antibody therapy.

Phase 2

Interventions

  • Biological: Emapalumab
    Summary: Emapalumab is a monoclonal antibody that targets interferon gamma (IFNγ) to inhibit its signaling, FDA approved in 2018 for hemophagocytic lymphohistiocytosis, used here for prophylaxis of cytokine release syndrome and neurotoxicity in bispecific antibody therapy (Source: Web Search).

Key Inclusion

  • Adults ≥18 years with large B-cell lymphoma refractory/relapsed after first-line therapy or R/R after ≥2 lines, planned for bispecific antibody therapy
  • Adults with R/R multiple myeloma after multiple lines including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody, planned for bispecific therapy
  • Measurable disease per Lugano Criteria (lymphoma) or IMWG criteria (myeloma)
  • ECOG performance status 0-2
  • ANC ≥1000/µL, platelets ≥50,000/µL, Hgb >7, lymphocytes ≥100/µL
  • Creatinine clearance ≥30 mL/min, ALT/AST ≤2.5x ULN, bilirubin ≤1.5 mg/dL
  • Cardiac ejection fraction ≥40%, oxygen saturation >92% on room air
  • Negative pregnancy test for females of childbearing potential with contraception agreement

Key Exclusion

  • History of Richter's transformation of CLL
  • Autologous stem cell transplant within 6 weeks or allogeneic transplant within 6 months
  • Uncontrolled infections including hepatitis B/C, active TB, CMV, EBV, or adenovirus
  • Active CNS disease or CNS disorder (seizure, cerebrovascular event) within 6 months
  • Myocardial infarction or significant cardiac disease within 6 months
  • Autoimmune disease requiring systemic immunosuppression or anticipated need for canakinumab, JAK inhibitors, TNF inhibitors, or tocilizumab
  • Live or attenuated vaccine within 4 weeks (BCG within 12 weeks)
  • Pregnant, breastfeeding, or unwilling to use contraception during study and 6 months after

NCT07040982

Pilot Study of Asciminib as a Maintenance Treatment Post Cellular Therapies in Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Genomic-based

Organization/Sponsor: City of Hope Medical Center


Example patient: A 45-year-old male with Ph+ ALL (BCR::ABL1 p190 detected by PCR) at day 60 post-allogeneic HSCT, fully engrafted with complete remission, ECOG 1, adequate counts and organ function, no active GVHD, and no cardiac abnormalities.

Phase N/A

Interventions

  • Drug: Asciminib
    Summary: Asciminib is an orally bioavailable allosteric Bcr-Abl1 tyrosine kinase inhibitor that binds the myristoyl pocket, inhibiting wild-type and mutant forms including T315I, used for Ph+ chronic myeloid leukemia and studied here for Ph+ ALL maintenance post-cellular therapy (FDA label, NCI Thesaurus).
  • Procedure: Survey Administration
    Summary: Survey administration involves presenting questionnaires to patients to collect self-reported data on experiences, anxiety, and trial participation willingness (NCI Thesaurus, Web Search).
  • Procedure: Echocardiography Test
    Summary: Echocardiography uses high-frequency ultrasound to image the heart, monitoring cardiac toxicity and dysfunction in patients receiving cancer therapy, especially anthracyclines (NCI Thesaurus, Web Search).
  • Procedure: Bone Marrow Biopsy
    Summary: Bone marrow biopsy removes core tissue containing bone spicules and hematopoietic elements to diagnose and evaluate leukemia, lymphoma, and other hematologic disorders (NCI Thesaurus, Web Search).
  • Procedure: Bone Marrow Aspiration
    Summary: Bone marrow aspiration extracts immature hematopoietic cells and blood from bone marrow to evaluate hematologic disorders, infections, and cytogenetics in leukemia and lymphoma (NCI Thesaurus, Web Search).
  • Procedure: Biospecimen Collection
    Summary: Biospecimen collection gathers tissue and fluid samples for testing, diagnostic, and research purposes to analyze genetic and molecular features in cancer (NCI Thesaurus, Web Search).

Key Inclusion

  • Age ≥18 years with Ph+ ALL diagnosed by FISH, PCR, NGS, or cytogenetics
  • Day +30 to +150 post-HSCT (Arm 1) or CD19 CAR T cell therapy (Arm 2)
  • Complete morphologic remission with <5% bone marrow blasts at day 30 post-cellular therapy
  • ECOG performance status ≤2
  • ANC ≥500/mm³ for 3 days, platelets ≥75,000/mm³, hemoglobin ≥9 g/dL
  • LVEF ≥50% and QTcB ≤480 ms
  • Adequate hepatic and renal function: bilirubin ≤1.5x ULN, AST/ALT ≤3x ULN, creatinine <1.5 mg/dL
  • Fully engrafted post-HSCT (Arm 1) or recovered from cytopenia post-CAR T (Arm 2)

Key Exclusion

  • Prior treatment failure with asciminib
  • History of pancreatitis within 1 year or chronic pancreatitis
  • Cardiac abnormalities: MI or CABG within 6 months, significant arrhythmias, long QT syndrome
  • Active grade 3 or higher GVHD within 14 days (Arm 1), except if on prednisone ≤0.5 mg/kg
  • Treatment with strong CYP3A inducers within 1 week of study start
  • Active uncontrolled infection or clinically significant uncontrolled illness
  • Other active malignancy that may interfere with study safety or efficacy
  • Pregnant or breastfeeding females

NCT04419909

Retreatment With CTL019/CTL119 in Patients With Late Relapse of B-Cell Lymphomas

Organization/Sponsor: University of Pennsylvania


Example patient: A 52-year-old man with relapsed CD19+ diffuse large B-cell lymphoma who previously achieved a 9-month complete response to CTL019 therapy on trial NCT02030834, now with measurable disease recurrence, ECOG status 1, normal cardiac and renal function, and no curative treatment options available.

Phase N/A

Interventions

  • Biological: CD19 redirected autologous T cells (CTL019 or CTL119 cells)
    Summary: Autologous T-lymphocytes genetically modified with a lentiviral vector expressing a chimeric antigen receptor (CAR) targeting CD19, containing co-stimulatory signaling domains. Upon administration, these CAR T-cells bind to CD19-expressing tumor cells, inducing selective toxicity in B-cell lineage malignancies. Source: NCI Thesaurus.

Key Inclusion

  • Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+
  • Previously treated on UPCC13413/NCT02030834 with CTL019/CTL119
  • Previous complete response to CAR T-cells with duration ≥6 months
  • No available curative treatment options with limited prognosis
  • Age ≥18 years
  • Measurable or assessable disease according to Revised Response Criteria for Malignant Lymphoma
  • Performance status (ECOG) 0 or 1
  • Left Ventricle Ejection Fraction (LVEF) >40%

Key Exclusion

  • Uncontrolled active infection
  • Active hepatitis B or hepatitis C infection
  • Class III/IV cardiovascular disability according to NYHA Classification
  • HIV infection
  • Active CNS involvement by malignancy
  • Prior CNS disease treated <4 weeks before enrollment
  • Known history or prior diagnosis of optic neuritis or inflammatory disease affecting CNS

NCT07478848

A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy

Organization/Sponsor: Abramson Cancer Center at Penn Medicine


Example patient: A 52-year-old male with relapsed diffuse large B-cell lymphoma, ECOG status 1, with multiple measurable lymph nodes on PET scan amenable to radiation, eligible for anti-CD19 CAR-T therapy without active infections or autoimmune contraindications.

Phase N/A

Interventions

  • Biological: CAR-T
    Summary: Autologous T-lymphocytes engineered with chimeric antigen receptors targeting specific antigens, used for B-cell lymphoma treatment (NCI Thesaurus).
  • Procedure: Radiation Therapy
    Summary: High-energy rays targeting cancer cells to kill them, used as bridging therapy before CAR-T; can be curative or palliative (NCI Thesaurus, FDA label).
  • Drug: Vancomycin 125mg
    Summary: Antibiotic targeting Gram-positive bacteria by preventing cell wall synthesis; used orally in this trial alongside radiation (Summary of Web Search).

Key Inclusion

  • Age 18 years or older
  • Pathologically confirmed B-cell lymphoma
  • Clinically eligible for standard of care anti-CD19 CAR-T
  • ECOG Performance Status ≤ 2
  • At least one site amenable to radiation with ability to treat ≥50% of involved sites
  • At least one site of measurable disease on CT or FDG PET
  • No anticipated need for additional therapy beyond bridging radiation
  • Negative pregnancy test or post-menopausal status for females

Key Exclusion

  • Unable to take oral vancomycin due to allergy or inability to swallow
  • Known history of vancomycin resistant enterococcus
  • Contraindications to radiation therapy including scleroderma, lupus, Crohn disease, ulcerative colitis, or pulmonary fibrosis
  • History of radiation pneumonitis or grade 4 radiation-related adverse event
  • Severe uncontrolled illness excluding standard CAR-T candidacy
  • Uncontrolled HIV with detectable viral load at screening
  • Active infection requiring antibiotics within 4 weeks prior to registration
  • Prior or concurrent malignancy interfering with safety or efficacy assessment

NCT07022678

A Randomized Double-Blinded Trial of Xylitol Dental Wipes for the Prophylaxis of Bloodstream Infections From Oral Organisms in Pediatric Patients With Acute Myeloid Leukemia

Organization/Sponsor: Children's Oncology Group


Example patient: A 12-year-old patient with newly diagnosed acute myeloid leukemia without Down syndrome, planned for cytarabine-based chemotherapy with expected prolonged neutropenia, who has visible teeth and no allergies to xylitol or grapes.

Phase N/A

Interventions

  • Device/Product: Xylitol-containing Oral Wipe
    Summary: An intraoral wipe containing xylitol that hydrates the mouth, relieves dry mouth symptoms, protects against cavities, and may prevent mucosal barrier injury-related bloodstream infections by keeping the oral mucosal barrier intact (NCI Thesaurus).
  • Other: Placebo Administration
    Summary: A medically inactive substance or intervention used as a control to evaluate treatment efficacy by comparing outcomes against no active treatment (NCI Thesaurus).
  • Procedure: Electronic Health Record Review
    Summary: Checking and assessing data present in an electronic health record to monitor patient outcomes and clinical parameters (NCI Thesaurus).
  • Drug: Cytarabine
    Summary: An antimetabolite nucleoside analog that inhibits DNA polymerase and replication by incorporating into DNA during S phase, indicated for treating acute leukemias as part of combination chemotherapy regimens (FDA label, NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: The act of gathering biospecimens such as tissue and fluid samples for testing, diagnostic, propagation, treatment, or research purposes (NCI Thesaurus).
  • Other: Best Practice
    Summary: An informed treatment recommendation expected to be helpful to the greatest number of people within a certain patient group (NCI Thesaurus).

Key Inclusion

  • Age 1 to 25 years at enrollment
  • Diagnosis of AML according to 2016 WHO classification
  • Newly diagnosed or relapsed AML
  • Planned to receive at least 2 consecutive cycles of myelosuppressive chemotherapy containing IV cytarabine
  • Expected severe neutropenia duration of at least 7 days per cycle
  • Minimum of one visible or erupted tooth
  • Agree to avoid xylitol containing gum or toothpaste during intervention
  • Written informed consent signed

Key Exclusion

  • Down syndrome-associated AML
  • Prior radiation treatment for cancer of oral cavity, head or neck in past 6 months
  • Known history of allergy to xylitol
  • Known history of allergy to grapes or grape flavoring
  • Actively being treated for oral organism related bloodstream infection
  • Unable to comply with use of oral dental wipes per practitioner assessment

NCT07591649

Safety and Efficacy of Expanded KIR-HLA Mismatched Natural Killer Cell Immunotherapy (AdaptNK) for High-Risk Myeloid Diseases as Bridge to Allogeneic Hematopoietic Stem Cell Transplantation Genomic-based

Organization/Sponsor: Masonic Cancer Center, University of Minnesota


Example patient: A 52-year-old with relapsed acute myeloid leukemia, HLA-C1/C1 type, Karnofsky score 80%, adequate organ function, off immunosuppression for 30 days, WBC 18,000, and no active infections or CNS disease.

Phase N/A

Interventions

  • BLA: IL-2
    Summary: Aldesleukin is a recombinant interleukin-2 that enhances lymphocyte activation and proliferation, indicated for metastatic renal cell carcinoma and melanoma. It carries risks including capillary leak syndrome and multi-organ toxicity. Source: FDA label, NCI Thesaurus.
  • ANDA: Cyclophosphamide
    Summary: Cyclophosphamide is an alkylating agent that cross-links DNA to inhibit replication, used for lymphomas, leukemias, and solid tumors. Key toxicities include bone marrow suppression, hemorrhagic cystitis, and secondary malignancies. Source: FDA label, NCI Thesaurus.
  • ANDA: Fludarabine
    Summary: Fludarabine phosphate is a fluorinated nucleoside analog that inhibits DNA synthesis via its triphosphate metabolite, indicated for refractory B-cell chronic lymphocytic leukemia. It requires careful monitoring due to immunosuppressive effects. Source: FDA label, NCI Thesaurus.
  • Biological: AdaptNK
    Summary: AdaptNK uses expanded KIR-HLA mismatched natural killer cells to directly kill leukemia cells, particularly in acute myeloid leukemia. It enhances NK cell activity against cancer cells. Source: Summary of Web Search.

Key Inclusion

  • 18-74 years with Karnofsky score ≥70%
  • 75 years and older: KPS ≥70%, HCT-CI <5, not frail by Fried criteria
  • HLA type C1/C1 or C2/C2
  • Adequate liver, renal, pulmonary and cardiac function
  • Off glucocorticoids and immunosuppressive medications for ≥28 days prior to AdaptNK infusion
  • WBC <25,000 before infusion
  • Prior treatment toxicities resolved to ≤grade 1
  • Adequate contraception from enrollment to 4 months after infusion

Key Exclusion

  • Myeloid neoplasms with germline background (except DDX41, TP53, RUNX1)
  • Acute promyelocytic leukemia
  • Myocardial infarction within 6 months
  • Pregnant or breastfeeding
  • Active CNS involvement with AML
  • Active autoimmune disease requiring immunosuppressive therapy
  • HIV-1/2 or hepatitis C/B positivity
  • Active systemic infections requiring anti-infective treatment

NCT07343934

Phase 1 Study of huCART19-IL18-eDHFR Cells in Patients With Relapsed or Refractory Follicular Lymphoma Genomic-based

Organization/Sponsor: University of Pennsylvania


Example patient: A 52-year-old male with grade 2 follicular lymphoma expressing CD19, relapsed 18 months after third-line rituximab-bendamustine therapy, ECOG 1, no prior CAR T-cell therapy, no active infections or autoimmune disease, and adequate cardiac and pulmonary function.

Phase 1

Interventions

  • Diagnostic: [18F]Fluoropropyl-Trimethoprim
    Summary: A radioactive PET/CT imaging tracer that detects bacterial infections by imaging uptake patterns; not specifically targeted for lymphoma (Source: Web Search).
  • Biological: huCART19-IL18-eDHFR cells
    Summary: Autologous CAR T-cells targeting CD19 on B-cell tumors, engineered to express IL-18 for enhanced T-cell persistence and immune response; includes costimulatory domains for improved function (Source: NCI Thesaurus).

Key Inclusion

  • Follicular lymphoma grades 1-3A
  • Relapsed or refractory after at least 2 prior systemic therapies including anti-CD20 antibody and alkylating agent
  • Progressed within 2 years after second or higher line therapy
  • CD19 expression documented by flow cytometry or IHC within 6 months
  • Progressive disease within 12 weeks of eligibility confirmation
  • ECOG Performance Status 0 or 1
  • Age 18 years or older
  • Adequate organ function including creatinine clearance ≥35 mL/min, LVEF ≥40%, pulse oxygen >92% on room air

Key Exclusion

  • Active hepatitis B or C infection
  • Active or chronic GVHD requiring systemic therapy
  • Dependence on systemic steroids or immunosuppressants
  • Prior huCART19 or huCART19-IL18 therapy
  • Active CNS involvement
  • Active autoimmune disease requiring immunosuppressive treatment equivalent to ≥10mg prednisone daily
  • Pregnant or nursing patients
  • Class III/IV cardiovascular disability or clinically apparent unstable arrhythmia

NCT07020533

A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant Genomic-based

Organization/Sponsor: City of Hope Medical Center


Example patient: A 52-year-old CMV-seropositive woman with acute myeloid leukemia in first remission scheduled for haploidentical stem cell transplant from her half-matched sibling donor using myeloablative conditioning without T-cell depletion.

Phase 1

Interventions

  • Biological: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
    Summary: A vaccine using modified vaccinia Ankara viral vector encoding CMV antigens to enhance immune response against cytomegalovirus in transplant recipients, particularly for leukemia and lymphoma patients (Web Search Summary).
  • Drug: Letermovir
    Summary: A non-nucleoside CMV DNA terminase complex inhibitor that prevents viral DNA cleavage and replication, indicated for CMV prophylaxis in seropositive hematopoietic stem cell transplant recipients (FDA label, NCI Thesaurus).
  • Biological: Recombinant Granulocyte Colony-Stimulating Factor
    Summary: A recombinant cytokine identical to endogenous G-CSF that stimulates proliferation and differentiation of neutrophil/granulocyte lineage progenitor cells for stem cell mobilization (NCI Thesaurus).
  • Procedure: Haploidentical Hematopoietic Cell Transplantation
    Summary: A transplant procedure transferring hematopoietic stem cells from a half-matched HLA donor to recipient for treatment of hematologic malignancies (NCI Thesaurus).
  • Procedure: Myeloablative Conditioning
    Summary: High-dose chemotherapy and radiation regimen that destroys bone marrow to eradicate leukemia or lymphoma cells before stem cell transplantation (Web Search Summary).
  • Procedure: Pheresis
    Summary: A blood separation procedure that removes specific blood components such as excess white blood cells and returns remaining components to the patient (Web Search Summary).
  • Other: Biospecimen Collection
    Summary: Systematic gathering of tissue and fluid samples for testing, research, and analysis of genetic and molecular features in transplant recipients (NCI Thesaurus).
  • Other: Electronic Health Record Review
    Summary: Assessment and analysis of patient data from electronic health records to monitor outcomes and improve clinical care (NCI Thesaurus).

Key Inclusion

  • Age 18-75 years for both donors and recipients
  • CMV seropositive recipients
  • Planned haploidentical peripheral blood or bone marrow transplant
  • Hematologic malignancies including lymphoma, acute leukemia in first or second remission, MDS, CML
  • HLA 2-6 mismatches with full haplotype match at minimum one allele
  • LVEF ≥50% and adequate organ function
  • Myeloablative or reduced intensity conditioning allowed
  • Minimal to no T-cell depletion of graft

Key Exclusion

  • Prior investigational CMV vaccine
  • Multiple myeloma or aplastic anemia
  • Planned use of alemtuzumab or T-cell depleting agents
  • Antiviral medications with CMV activity except letermovir prophylaxis
  • Active autoimmune conditions requiring immunosuppression within 5 years
  • Refractory leukemia or second HCT
  • AML/ALL beyond second remission or CML in blast crisis
  • Pregnant or breastfeeding

NCT07392970

A Pilot Clinical Trial of Motixafortide for Measurable Residual Disease (MRD) Sensitization in Acute Myeloid Leukemia (AML) Genomic-based

Organization/Sponsor: Washington University School of Medicine


Example patient: A 52-year-old man with newly diagnosed AML who completed two cycles of induction chemotherapy, achieved complete remission by CBC with ECOG status 1, and is scheduled for bone marrow MRD assessment including flow cytometry and NGS panels.

Phase N/A

Interventions

  • Drug: Motixafortide
    Summary: A CXCR4 antagonist that blocks SDF-1 binding, mobilizing hematopoietic stem cells from bone marrow to peripheral blood and potentially reducing tumor cell proliferation and migration in AML MRD sensitization (FDA label, NCI Thesaurus).

Key Inclusion

  • Diagnosed with acute myeloid leukemia (AML), excluding APL
  • Treated with 1-2 cycles of front-line chemotherapy
  • Achieved CBC parameters compatible with complete remission per ELN 2022
  • Planning standard of care MRD assays including flow cytometry, NGS, and PCR
  • At least 18 years of age
  • ECOG performance status ≤ 2
  • Life expectancy > 3 months
  • Adequate organ function with creatinine clearance > 30 mL/min

Key Exclusion

  • More than 5% blasts in peripheral blood within 5 days prior to enrollment
  • Prior history of allogeneic stem cell transplant
  • Prior or concurrent malignancy interfering with safety or efficacy assessment
  • Currently receiving other investigational agents
  • Allergic reactions to compounds similar to motixafortide
  • Uncontrolled infection, symptomatic heart failure, unstable angina, or cardiac arrhythmia
  • Pregnant or breastfeeding
  • HIV with detectable viral load or not on effective therapy for 6 months

NCT07464951

Phase 1 Trial of Autologous CD123-Directed CAR T-Cells (CART123) as Monotherapy or in Combination With Ruxolitinib in Relapsed/Refractory Acute Myeloid Leukemia

Organization/Sponsor: Children's Hospital of Philadelphia


Example patient: A 16-year-old with AML in second relapse after achieving complete remission twice, with 5% bone marrow blasts by flow cytometry, adequate cardiac and pulmonary function, Karnofsky score of 60, and an identified matched sibling donor available for transplant.

Phase 1

Interventions

  • Biological: Anti-CD123 LV redirected T cells (CART123)
    Summary: Autologous CAR T-cells targeting CD123 on AML cells using a chimeric antigen receptor with anti-CD123 scFv coupled to 4-1BB and CD3-zeta signaling domains to induce selective tumor cell lysis. Source: NCI Thesaurus.
  • Drug: Ruxolitinib (JAKAVI®)
    Summary: JAK1/2 tyrosine kinase inhibitor that blocks JAK-STAT signaling pathways to reduce inflammation and cellular proliferation, FDA-approved for myelofibrosis, polycythemia vera, and graft-versus-host disease. Source: FDA label, NCI Thesaurus.

Key Inclusion

  • AML in second or greater relapse, post-transplant relapse, or chemotherapy-refractory disease
  • Age 0-29 years (Cohort A) or 1-29 years (Cohort B)
  • Flow cytometric confirmation of myeloid leukemia at least 0.1%
  • Identified stem cell donor with ability to proceed rapidly to transplant
  • Adequate organ function including creatinine, liver, pulmonary, and cardiac parameters
  • Lansky or Karnofsky performance score ≥50
  • LVEF ≥45% or LVSF ≥28%
  • DLCO ≥40% if PFTs clinically appropriate

Key Exclusion

  • Active hepatitis B or C
  • HIV infection
  • Active acute or chronic GVHD requiring systemic therapy
  • Concurrent systemic steroids or immunosuppression at cell infusion or collection
  • CNS disease progressive on therapy or with parenchymal lesions
  • Pregnant or nursing
  • Uncontrolled active infection

NCT07254793

A Feasibility/Pilot First-in-human Study of Exercise-mobilized NK-enriched Donor Lymphocyte Infusions (DLI-X) to Prevent or Treat Leukemia Relapse After Allogeneic Hematopoietic Cell Transplantation

Organization/Sponsor: University of Arizona


Example patient: A 42-year-old male with acute myeloid leukemia who underwent matched sibling donor HCT three months ago, has no active GvHD, normal organ function, Karnofsky score of 80%, and has a 35-year-old sibling donor available for exercise-mobilized DLI.

Phase N/A

Interventions

  • Biological: Standard Therapeutic DLI
    Summary: Uses donor lymphocytes to treat leukemia or lymphoma relapse post-transplant by leveraging donor T-cells' graft-versus-tumor effect to target residual cancer cells. Source: Summary of Web Search.
  • Biological: Exercise Mobilized Therapeutic DLI
    Summary: Enhances donor lymphocyte infusions through exercise mobilization of NK-cells and T-cells with higher anti-tumor activity to fight leukemia and lymphoma post-transplantation. Source: Summary of Web Search.
  • Biological: Standard Prophylactic DLI
    Summary: Prevents leukemia or lymphoma relapse post-transplant by infusing donor lymphocytes to stimulate graft-versus-tumor effect and activate immune system against residual malignant cells. Source: Summary of Web Search.
  • Biological: Exercise Mobilized Prophylactic DLI
    Summary: Enhances donor lymphocyte infusions with exercise to improve immune response against leukemia relapse post-HCT by targeting leukemia cells with mobilized immune cells. Source: Summary of Web Search.

Key Inclusion

  • Diagnosis of acute leukemia, MDS, CML or NHL
  • Undergoing myeloablative or reduced intensity matched sibling or haploidentical HCT
  • Age 0-65 years for recipients
  • Locally available healthy matched or haploidentical related donor age 12-50 years
  • Donor able to complete fitness evaluation for VO2max and peak cycling power

Key Exclusion

  • Acute grade III-IV aGvHD or moderate/severe chronic GvHD
  • Requiring immunosuppression therapy for GvHD treatment
  • AST/ALT greater than 5x ULN or bilirubin greater than 2x ULN
  • DLCO less than 40% or O2 Sat less than 92%
  • Left ventricular ejection fraction less than 35%
  • Uncontrolled or severe bacterial, fungal or viral infection
  • Karnofsky score less than 60% or Lansky score less than 50%
  • Positive pregnancy test for women of childbearing age

NCT07502872

TPG: a Phase 2 Trial of Polatuzumab Vedotin, Glofitamab, and Tafasitamab as Chemotherapy-sparing First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma Genomic-based

Organization/Sponsor: Brown University


Example patient: A 52-year-old man with newly diagnosed diffuse large B-cell lymphoma NOS with MYC and BCL2 rearrangements, ECOG performance status 1, FDG-avid disease on PET-CT, no CNS involvement, and adequate organ function who has not received prior systemic therapy.

Phase 2

Interventions

  • BLA: Obinutuzumab
    Summary: Obinutuzumab is a glycoengineered humanized anti-CD20 monoclonal antibody that induces antibody-dependent cellular cytotoxicity and apoptosis in CD20-expressing B cells, indicated for chronic lymphocytic leukemia and follicular lymphoma (FDA label, NCI Thesaurus).
  • BLA: Glofitamab
    Summary: Glofitamab is a bispecific CD20-directed CD3 T-cell engager that simultaneously binds CD20 on B-cell lymphomas and CD3 on T cells to redirect T-cell-mediated killing, indicated for relapsed/refractory DLBCL (FDA label, NCI Thesaurus).
  • BLA: Polatuzumab vedotin
    Summary: Polatuzumab vedotin is a CD79b-directed antibody-drug conjugate delivering microtubule inhibitor MMAE via protease-cleavable linker to induce apoptosis in B-cell lymphomas, indicated for DLBCL and high-grade B-cell lymphoma (FDA label, NCI Thesaurus).
  • BLA: Tafasitamab
    Summary: Tafasitamab is an Fc-engineered humanized anti-CD19 monoclonal antibody that enhances antibody-dependent cellular cytotoxicity and phagocytosis against CD19-expressing B cells, indicated for relapsed/refractory DLBCL and follicular lymphoma (FDA label, NCI Thesaurus).

Key Inclusion

  • Age ≥18 years
  • Histologically confirmed DLBCL or HGBL per WHO 5th edition classification
  • FDG-avid disease by PET-CT Lugano criteria
  • No prior systemic therapy except corticosteroids, single chemotherapy cycle, local radiation, or prior indolent lymphoma treatment
  • ECOG performance status 0, 1, or 2
  • Absolute neutrophil count ≥1.0 x 10^9/L and platelet count ≥75 x 10^9/L
  • Creatinine ≤1.5 mg/dL or GFR ≥40 mL/min/1.73m2
  • Negative SARS-CoV-2 test

Key Exclusion

  • Central nervous system involvement by lymphoma
  • Prior solid organ or allogeneic stem cell transplantation
  • Known NYHA class 3/4 heart failure, LVEF <30%, or active ischemic heart disease
  • COPD requiring continuous oral corticosteroids or chronic oxygen
  • Active bacterial infection requiring antibiotics
  • Active hepatitis B or C infection (with specific exceptions)
  • HIV with detectable viral load or CD4 <200 cells/mm3
  • Autoimmune disease requiring systemic immunosuppressive therapy

NCT07061951

A Phase 2 Pilot Study of Mirdametinib in Relapsed Refractory Chronic Lymphocytic Leukemia

Organization/Sponsor: National Cancer Institute (NCI)


Example patient: A 62-year-old man with relapsed CLL after ibrutinib and venetoclax therapy, presenting with progressive lymphadenopathy, lymphocytosis of 45,000/mcL, ECOG status 1, adequate organ function, and no active infections or cardiac issues.

Phase 2

Interventions

  • Drug: Mirdametinib
    Summary: Mirdametinib is an oral MEK inhibitor that selectively blocks MAPK/ERK kinase, inhibiting tumor cell proliferation via the RAS/RAF/MEK/ERK signaling pathway. FDA-approved for neurofibromatosis type 1 plexiform neurofibromas, it is being studied for relapsed CLL with constitutive ERK activation after BTK inhibitor therapy. Source: FDA label and NCI Thesaurus.
  • Procedure: Echocardiography Test
    Summary: Echocardiography uses ultrasound to create heart images, monitoring cardiac toxicity and therapy-related dysfunction in cancer patients. Source: NCI Thesaurus and Web Search.
  • Procedure: Computed Tomography
    Summary: CT scans use X-rays and computer reconstruction to create cross-sectional body images, assessing lymphadenopathy and tumor progression in CLL patients. Source: NCI Thesaurus.
  • Procedure: Bone Marrow Biopsy
    Summary: Bone marrow biopsy removes core tissue containing bone and hematopoietic elements for microscopic analysis, diagnosing and evaluating CLL and bone marrow involvement. Source: NCI Thesaurus.
  • Procedure: Biospecimen Collection
    Summary: Biospecimen collection gathers tissue and fluid samples for research, analyzing genetic and molecular features to understand disease mechanisms and treatment responses. Source: NCI Thesaurus.

Key Inclusion

  • Histologically or cytologically confirmed CLL or SLL with CD19, CD5, CD23 coexpression
  • Current indication for treatment per iwCLL 2018 Guidelines
  • Measurable disease: lymphocytosis >5000/mcL, lymphadenopathy >1.5 cm, or bone marrow involvement >30%
  • At least two prior therapies including BTK inhibitor and BCL2 inhibitor
  • Age ≥18 years
  • ECOG performance status ≤2
  • Absolute neutrophil count ≥500/mcL, platelets ≥20,000/mcL
  • GFR ≥50 ml/min

Key Exclusion

  • Residual toxicities >grade 1 from prior anti-cancer therapy except alopecia
  • Receiving other investigational agents
  • Concurrent strong P-gp, BCRP, or CYP3A4 inhibitors/inducers without washout
  • Uncontrolled intercurrent illness
  • Pregnant or breastfeeding
  • Active infection requiring IV antibiotics
  • History or current evidence of glaucoma or significant ophthalmological abnormalities
  • QTc >470 ms

NCT07306832

A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Organization/Sponsor: AbbVie


Example patient: A 12-year-old with CD123-positive acute myeloid leukemia in third relapse, Karnofsky score of 60, with 15% bone marrow blasts and no cardiac disease or prior transplant.

Phase 1

Interventions

  • Drug: Pivekimab Sunirine
    Summary: An antibody-drug conjugate targeting CD123 (IL-3 receptor alpha chain) with a cytotoxic DNA-alkylating indolino-benzodiazepine payload that induces cell cycle arrest and apoptosis in CD123-overexpressing cancer cells, used for antineoplastic activity (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed acute myeloid leukemia in second or greater relapse or refractory to second or subsequent line therapy
  • CD123-positive myeloid leukemic blasts by flow cytometry
  • ≥5% myeloid leukemic blasts in bone marrow
  • Lansky or Karnofsky score ≥50 or ECOG score ≤2
  • CNS1, CNS2, or CNS3 disease without clinical neurologic symptoms

Key Exclusion

  • Known clinically significant cardiac disease
  • Down syndrome
  • Acute promyelocytic leukemia or juvenile myelomonocytic leukemia
  • Symptomatic CNS3 disease
  • Prior history of veno-occlusive disease/sinusoidal obstructive syndrome
  • Hematopoietic stem cell transplant within 6 months or active GvHD
  • Prior CAR-T therapy
  • Currently receiving anticancer therapy except intrathecal therapy

NCT07479797

A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

Organization/Sponsor: Gilead Sciences


Example patient: A 58-year-old male with diffuse large B-cell lymphoma who achieved partial response after 6 cycles of R-CHOP first-line therapy, has an ECOG status of 1, measurable 2.5 cm cervical lymph node, adequate organ function, and no prior CAR T-cell therapy.

Phase 3

Interventions

  • Drug: Cyclophosphamide
    Summary: Cyclophosphamide is an alkylating agent that cross-links DNA to inhibit replication, used for treating lymphomas, leukemias, and solid tumors. It is converted to active metabolites in the liver that disrupt cancer cell division and immune function (FDA label, NCI Thesaurus).
  • Drug: Fludarabine
    Summary: Fludarabine phosphate is a fluorinated nucleoside analog that inhibits DNA synthesis via its triphosphate metabolite, blocking DNA polymerase and ribonucleotide reductase. It is indicated for B-cell chronic lymphocytic leukemia refractory to alkylating agents (FDA label, NCI Thesaurus).
  • Biological: Axicabtagene Ciloleucel
    Summary: Axicabtagene ciloleucel is an autologous anti-CD19 CAR T-cell therapy for treating relapsed or refractory large B-cell lymphoma.
  • Biological: KITE-753
    Summary: KITE-753 is an autologous anti-CD19/CD20 dual-targeting CAR T-cell therapy designed for relapsed/refractory large B-cell lymphoma, targeting both CD19 and CD20 antigens on B-cells (Web Search).

Key Inclusion

  • Large B-cell lymphoma with chemorefractory disease to first-line therapy or relapsed disease within 12 months
  • Prior therapy must have included anti-CD20 antibody and anthracycline-containing chemotherapy
  • At least one measurable lesion >1.5 cm for lymph node or >1.0 cm for extranodal lesion
  • ECOG performance status ≤2
  • Adequate bone marrow function: ANC ≥1,000/μL or ≥500/μL if bone marrow involvement
  • Creatinine clearance ≥30 mL/min
  • Cardiac ejection fraction ≥40% with no Grade 3+ pericardial effusion
  • Baseline oxygen saturation >92% on room air

Key Exclusion

  • Prior CAR T-cell therapy or other cell-based therapy
  • Specific LBCL subtypes including Richter's transformation, Burkitt lymphoma, primary CNS lymphoma, HGBCL with 11q aberrations
  • Active uncontrolled infection requiring IV antimicrobials
  • Secondary CNS lymphoma or cardiac atrial/ventricular lymphoma involvement
  • History of stroke or TIA within 6 months or active seizure disorder requiring anticonvulsants
  • Myocardial infarction or NYHA Class II+ heart failure within 6 months
  • Autoimmune disease requiring systemic immunosuppression within 90 days
  • Pregnant or breastfeeding females

NCT06996119

Pilot Study of Emapalumab With Post-Transplant Cyclophosphamide as Graft-Versus-Host Disease Prophylaxis for Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation Genomic-based

Organization/Sponsor: City of Hope Medical Center


Example patient: A 52-year-old patient with acute myeloid leukemia in complete remission with negative minimal residual disease, Karnofsky performance status of 80%, adequate organ function, and an 8/8 HLA-matched unrelated donor, planned for reduced-intensity conditioning with fludarabine/melphalan prior to allogeneic stem cell transplantation.

Phase N/A

Interventions

  • Drug: Emapalumab
    Summary: Monoclonal antibody targeting interferon gamma to inhibit its signaling, used to treat hemophagocytic lymphohistiocytosis and studied for graft-versus-host disease prophylaxis (Summary of Web Search).
  • Drug: Cyclophosphamide
    Summary: Alkylating agent that cross-links DNA to disrupt cancer cell replication, used for lymphomas, leukemias, and as post-transplant immunosuppression (FDA label, NCI Thesaurus).
  • Drug: Tacrolimus
    Summary: Calcineurin inhibitor that suppresses T-cell activation by preventing interleukin-2 production, used to prevent graft-versus-host disease in transplants (FDA label, NCI Thesaurus).
  • Drug: Mycophenolate Mofetil
    Summary: Immunosuppressant that inhibits inosine monophosphate dehydrogenase to suppress lymphocyte proliferation, used to prevent organ rejection in transplants (FDA label, NCI Thesaurus).
  • Drug: Fludarabine
    Summary: Fluorinated nucleoside analog that inhibits DNA synthesis by blocking DNA polymerase and ribonucleotide reductase, used in conditioning regimens and CLL treatment (FDA label, NCI Thesaurus).
  • Drug: Melphalan
    Summary: Bifunctional alkylating agent that induces DNA cross-linkages to inhibit DNA and RNA synthesis, used in conditioning regimens for transplantation (FDA label, NCI Thesaurus).
  • Drug: Busulfan
    Summary: Alkylating agent that damages DNA through alkylation, used in myeloablative conditioning regimens prior to hematopoietic cell transplantation (FDA label, NCI Thesaurus).
  • Procedure: Hematopoietic Cell Transplantation
    Summary: Transplantation of hematopoietic stem cells from donor to patient for treatment of malignant and non-malignant diseases (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Gathering tissue and fluid samples for testing, diagnostic, and research purposes to analyze disease mechanisms (NCI Thesaurus).
  • Other: Questionnaire Administration
    Summary: Patient self-reported outcome assessment to measure quality of life and treatment effects (NCI Thesaurus).
  • Diagnostic Test: Multigated Acquisition Scan
    Summary: Diagnostic test using radioactive tracer to evaluate cardiac ventricular pumping function and monitor cardiotoxicity (NCI Thesaurus).
  • Diagnostic Test: Echocardiography Test
    Summary: Ultrasound imaging to monitor cardiac function and detect therapy-related cardiac dysfunction (NCI Thesaurus).
  • Diagnostic Test: Computed Tomography
    Summary: X-ray imaging method to construct cross-sectional scans for monitoring disease progression and treatment response (NCI Thesaurus).

Key Inclusion

  • Age 18-75 years with AML or MDS in complete remission, bone marrow blasts <5%, AML must be MRD negative
  • Planned reduced-intensity conditioning with fludarabine/melphalan or busulfan/fludarabine prior to allogeneic HCT
  • 8/8 HLA-matched related or unrelated donor using mobilized peripheral blood stem cells
  • Karnofsky performance status ≥70% (≥80% if age >70 with HCT-CI ≤2)
  • Adequate organ function: creatinine clearance ≥60 mL/min, LVEF ≥50%, bilirubin ≤1.5x ULN, AST/ALT ≤3x ULN
  • Pulmonary function: FEV1, FVC, DLCO ≥50% predicted or O2 saturation >92% on room air
  • Seronegative for HIV, HCV, HBV or undetectable viral load if seropositive
  • Negative pregnancy test and agreement to use effective contraception through 180 days post-HCT

Key Exclusion

  • Prior allogeneic hematopoietic cell transplantation
  • Cancer therapies within two weeks of conditioning except targeted agents for hematologic malignancies
  • History of allergic reactions to compounds similar to study agent
  • Active uncontrolled infections (bacterial, viral, fungal)
  • Other active malignancy
  • Clinically significant uncontrolled illness
  • Pregnant or breastfeeding
  • Psychological issues, lack of appropriate caregivers, or medication non-compliance

NCT07250646

A Phase 1 Study of Rebecsinib, a Spliceosome Modulator That Inhibits ADAR1, in Patients With Relapsed or Refractory Secondary Acute Myeloid Leukemia or Higher-Risk Myelofibrosis Genomic-based

Organization/Sponsor: Aspera Biomedicines, Inc.


Example patient: A 62-year-old male with secondary AML evolved from MDS with 8% bone marrow blasts, ECOG 1, who relapsed after azacitidine and venetoclax therapy, ineligible for transplant due to comorbidities, with creatinine clearance of 75 mL/min.

Phase 1

Interventions

  • Drug: rebecsinib
    Summary: Rebecsinib is a selective inhibitor of ADAR1 that targets leukemia stem cells to prevent their generation and self-renewal, studied for blood cancers like leukemia (Web Search).

Key Inclusion

  • Refractory myeloid neoplasm: secondary AML evolved from MDS, MPN, MDS/MPN, or higher-risk myelofibrosis with >5% bone marrow blasts
  • Ineligible for bone marrow transplantation at enrollment
  • Relapsed or refractory to available therapies including anthracycline, epigenetic modifiers, or venetoclax
  • Prior FLT3 or IDH inhibitor if mutation present
  • At least one line of therapy if unfit for intensive chemotherapy, or two lines if received intensive induction
  • Creatinine clearance >60 mL/min
  • Age 18 years or older
  • ECOG performance status 0-2

Key Exclusion

  • Previous hematopoietic cell transplant
  • Chemotherapy or investigational drug within 2 weeks or 5 half-lives
  • Active infection with HIV, HBV, or HCV
  • Concurrent malignancy or prior malignancy within 3 years
  • Known CNS involvement by malignancy
  • Myocardial infarction within 6 months or QTc ≥470 msec
  • On CYP3A4, CYP2C9, CYP2C19, CYP2B6 inducers/inhibitors or hepatic uptake transporter substrates
  • Pregnant or breastfeeding

NCT07283640

A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia Genomic-based

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 65-year-old patient with newly diagnosed KMT2A-rearranged B-cell ALL, ECOG performance status 1, ejection fraction 55%, creatinine clearance 70 ml/min, no active infections, and no cardiac events in the past year.

Phase 1

Interventions

  • Biological: Blinatumomab
    Summary: Bispecific CD19-directed CD3 T-cell engager that brings T-cells and CD19-positive B-cells together to induce cytotoxic killing of leukemic cells, indicated for B-cell precursor ALL including MRD-positive and relapsed/refractory settings (FDA label, NCI Thesaurus).
  • Drug: Revumenib
    Summary: Oral menin inhibitor that blocks menin-KMT2A protein interaction, preventing formation of the menin-KMT2A complex and reducing downstream gene expression that drives proliferation in KMT2A-rearranged leukemia (FDA label, NCI Thesaurus).

Key Inclusion

  • Adults >18 years with relapsed/refractory KMT2A-rearranged B-cell ALL (>5% blasts)
  • Adults >18 years with persistent measurable residual disease KMT2A-rearranged B-cell ALL
  • Newly diagnosed KMT2A-rearranged B-cell ALL patients >60 years or unfit for intensive chemotherapy
  • ECOG performance status <2 for relapsed/refractory patients
  • Adequate organ function: bilirubin <1.5x ULN, ALT/AST <3x ULN, lipase/amylase <1.5x ULN
  • Ejection fraction >50%, GFR >60 ml/min/1.73m2
  • WBC count <25,000/uL at enrollment
  • Weight at least 40 kg

Key Exclusion

  • Active serious infection not controlled by antibiotics
  • Untreated CNS disease
  • Myocardial infarction, CHF NYHA Class >II, CVA, or TIA within 6 months
  • QTcF >450 msec or personal/family history of long QT syndrome
  • Cirrhosis with Child Pugh score B or C
  • Active hepatitis B with detectable HBV DNA or hepatitis C with detectable HCV RNA
  • Detectable HIV viral load within previous 6 months
  • Active secondary malignancy expected to shorten survival to <1 year

NCT07557056

A Phase 2 Study of Nemtabrutinib and Venetoclax as Frontline Treatment for Chronic Lymphocytic Leukemia (CLL)

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 62-year-old male with newly diagnosed treatment-naïve CLL presenting with progressive lymphadenopathy (12 cm nodes), fatigue, and night sweats, ECOG performance status 1, adequate organ function, and no prior CLL therapy or significant cardiovascular disease.

Phase 2

Interventions

  • Drug: Venetoclax
    Summary: Venetoclax is an orally bioavailable BCL-2 inhibitor that induces apoptosis in cancer cells by blocking BCL-2 protein, which promotes cancer cell survival. FDA-approved for CLL/SLL and AML, it restores apoptotic processes in tumor cells overexpressing BCL-2. Source: FDA label, NCI Thesaurus.
  • Drug: Nemtabrutinib
    Summary: Nemtabrutinib is an orally available reversible BTK inhibitor that non-covalently binds to both wild-type and C481S mutated BTK, preventing BCR signaling pathway activation. It inhibits growth of malignant B-cells and overcomes resistance mutations. Source: NCI Thesaurus.
  • Procedure: Questionnaire Administration
    Summary: The act of having an individual fill out a questionnaire to assess patient-reported outcomes, quality of life, and treatment effects. Source: NCI Thesaurus.
  • Procedure: Computed Tomography
    Summary: A method of examining body structures by scanning with X-rays and using a computer to construct cross-sectional images for monitoring disease progression and treatment response. Source: NCI Thesaurus.
  • Procedure: Bone Marrow Biopsy
    Summary: Removal of core tissue containing bone spicules and hematopoietic elements for diagnosis and evaluation of hematologic malignancies and tumor spread. Source: NCI Thesaurus.
  • Procedure: Bone Marrow Aspiration
    Summary: Aspiration of immature hematopoietic elements and blood from bone marrow for evaluation of hematopoietic disorders, infectious diseases, and cytogenetic studies. Source: NCI Thesaurus.
  • Procedure: Biospecimen Collection
    Summary: The act of gathering biospecimens for testing, diagnostic, propagation, treatment, or research purposes to analyze genetic and molecular features. Source: NCI Thesaurus.

Key Inclusion

  • Confirmed diagnosis of treatment-naïve CLL/SLL meeting 2018 iwCLL criteria
  • At least 18 years of age
  • Meets criteria for treatment per 2018 iwCLL guidelines (progressive disease, symptomatic splenomegaly/lymphadenopathy, or constitutional symptoms)
  • ECOG performance status ≤2
  • Adequate bone marrow function (ANC ≥1000/mm³, platelets ≥50,000/mm³, hemoglobin ≥8 g/dL) unless cytopenia due to marrow involvement
  • Creatinine clearance ≥30 mL/min
  • Ability to swallow oral medication
  • Participants with HBV, HCV, or HIV eligible if viral load undetectable and on appropriate therapy

Key Exclusion

  • Other malignancies with life expectancy <2 years
  • Clinically significant cardiovascular disease (symptomatic arrhythmias, CHF, MI within 6 months, NYHA class 3-4)
  • Active HBV/HCV infection
  • Diagnosis of Richter transformation
  • Active CNS involvement
  • Prior CLL/SLL directed therapy
  • QTc prolongation (QTcF >450 msecs) or significant ECG abnormalities
  • Currently receiving P-gp substrates with narrow therapeutic index, CYP3A strong inducers/inhibitors

NCT06738368

Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) ± Rituximab + Recombinant Erwinia Asparaginase (JZP458; Rylaze®) for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative Acute Lymphoblastic Lymphoma/Leukemia Genomic-based

Organization/Sponsor: University of Washington


Example patient: A 52-year-old man with newly diagnosed Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia detected by flow cytometry in bone marrow, ECOG performance status 1, creatinine clearance 75 ml/min, normal liver function, and no prior ALL treatment.

Phase N/A

Interventions

  • Drug: Vincristine
    Summary: Vincristine is a vinca alkaloid chemotherapy agent that disrupts microtubule formation during cell division, arresting tumor cells in metaphase and inducing apoptosis in rapidly dividing cancer cells; indicated for acute leukemia and lymphomas (FDA label, NCI Thesaurus).
  • Drug: Rituximab
    Summary: Rituximab is a chimeric monoclonal antibody targeting CD20 antigen on B cells, inducing cytolysis through complement-dependent and antibody-dependent mechanisms; indicated for CD20-positive B-cell malignancies including non-Hodgkin's lymphoma and chronic lymphocytic leukemia (FDA label, NCI Thesaurus).
  • Drug: Prednisone
    Summary: Prednisone is a synthetic glucocorticoid that binds nuclear receptors to suppress proinflammatory cytokine production, decrease circulating lymphocytes, and induce apoptosis in sensitive tumor cells; used for inflammatory, autoimmune, and neoplastic conditions (FDA label, NCI Thesaurus).
  • Procedure: Positron Emission Tomography
    Summary: PET imaging uses positron-emitting radionuclides attached to metabolically active substances like FDG to visualize tissue metabolic activity and detect cancer through gamma radiation detection (NCI Thesaurus).
  • Drug: Pegfilgrastim
    Summary: Pegfilgrastim is a pegylated recombinant human granulocyte colony-stimulating factor (G-CSF) that stimulates neutrophil production from bone marrow to reduce chemotherapy-induced neutropenia and infection risk (FDA label, NCI Thesaurus).
  • Drug: Filgrastim
    Summary: Filgrastim is a recombinant human G-CSF that binds and activates G-CSF receptors to stimulate neutrophil production and release from bone marrow, preventing severe neutropenia in chemotherapy, AML, and transplant settings (FDA label, NCI Thesaurus).
  • Drug: Etoposide
    Summary: Etoposide is a semisynthetic podophyllotoxin derivative that inhibits topoisomerase II, causing DNA strand breaks and preventing DNA replication and transcription, leading to apoptotic cell death primarily in G2 and S phases (FDA label, NCI Thesaurus).
  • Drug: Doxorubicin
    Summary: Doxorubicin is an anthracycline antibiotic that intercalates DNA, inhibits topoisomerase II, and generates oxygen free radicals, causing DNA damage and cell death in rapidly dividing cancer cells; indicated for leukemias, lymphomas, and solid tumors (FDA label, NCI Thesaurus).
  • Drug: Cyclophosphamide
    Summary: Cyclophosphamide is an alkylating agent converted in the liver to active metabolites that cross-link DNA, inhibiting DNA replication and initiating cell death; indicated for lymphomas, leukemias, and solid tumors (FDA label, NCI Thesaurus).
  • Procedure: Computed Tomography
    Summary: CT scanning uses X-rays and computer processing to construct cross-sectional images of body structures for examining internal anatomy and monitoring disease progression (NCI Thesaurus).
  • Procedure: Bone Marrow Collection
    Summary: Bone marrow collection is any process that harvests bone marrow for clinical or manufacturing purposes (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Biospecimen collection is the act of gathering tissue and fluid samples for testing, diagnostic, propagation, treatment, or research purposes (NCI Thesaurus).
  • Drug: Asparaginase Erwinia chrysanthemi
    Summary: Recombinant Erwinia asparaginase hydrolyzes L-asparagine to L-aspartic acid and ammonia, depleting asparagine required for leukemic cell protein synthesis; indicated for ALL and LBL in patients hypersensitive to E. coli-derived asparaginase (FDA label, NCI Thesaurus).

Key Inclusion

  • Adults age 18 years and older with newly-diagnosed Ph- B-ALL or T-ALL
  • Unsuitable candidate for pediatric-inspired regimen due to older age (≥40 years) or toxicity concerns
  • Marrow or blood involvement by ALL detectable by multi-parameter flow cytometry
  • ECOG performance status 0 to 2 (or 3 if directly secondary to ALL)
  • Calculated creatinine clearance ≥60 ml/min/1.73 m² by MDRD equation
  • Total bilirubin ≤2.0 x ULN (or ≤4.0 x ULN for Gilbert's disease)
  • AST/ALT ≤5.0 x ULN (or ≤8.0 x ULN if hepatic involvement by ALL)
  • Anticipated survival of at least 3 months independent of ALL

Key Exclusion

  • Prior systemic therapy for ALL except limited corticosteroids or cytarabine for symptom control
  • Burkitt lymphoma/leukemia
  • Isolated extramedullary or known parenchymal CNS disease
  • Known hypersensitivity or intolerance to any agents under investigation
  • Known history of grade 3+ pancreatitis or chronic pancreatic insufficiency
  • Known active chronic liver disease including cirrhosis or NAFLD
  • Pregnant or nursing
  • Medical or psychiatric conditions precluding safe participation

NCT07013435

Thriving Beyond Treatment: A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship.

Organization/Sponsor: Massachusetts General Hospital


Example patient: A 45-year-old Spanish-speaking woman who completed chemotherapy and radiation for diffuse large B-cell lymphoma 18 months ago, now in remission without psychiatric or cognitive disorders.

Phase N/A

Interventions

  • Behavioral: SMART3RP-Lymphoma
    Summary: A mind-body program using stress management and relaxation techniques to enhance resilience and improve quality of life in lymphoma survivors adapting to chronic post-treatment stress (Summary of Web Search).
  • Behavioral: Health Education Program
    Summary: An educational intervention designed to improve patient understanding and engagement, reduce participation barriers, and enhance outcomes, often using electronic health tools (Summary of Web Search).

Key Inclusion

  • English or Spanish speaking adults
  • 18 years or older at enrollment
  • Within 2 years of completing active curative treatment for lymphoma
  • Completed surgery, chemotherapy, immunotherapy, radiation therapy, or other treatment

Key Exclusion

  • Active psychiatric comorbidity
  • Active cognitive comorbidity

NCT07471841

Pilot Single Arm Phase 2 Study of Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax Genomic-based

Organization/Sponsor: Hoosier Cancer Research Network


Example patient: A 62-year-old man with relapsed IDH1-mutated AML after one prior line of venetoclax-based therapy, ECOG performance status 1, creatinine clearance 45 mL/min, no CNS involvement, and no recent stem cell transplant.

Phase 2

Interventions

  • Drug: Azacitidine (AZA)
    Summary: Azacitidine is a hypomethylating agent that inhibits DNA methylation, promoting differentiation of hematopoietic cells in acute myeloid leukemia and myelodysplastic syndromes, often used in older patients unable to tolerate intensive chemotherapy (Web Search).
  • Drug: Olutasidenib
    Summary: Olutasidenib is an oral IDH1 inhibitor that targets IDH1(R132) mutations in relapsed/refractory AML, blocking production of oncometabolite 2-hydroxyglutarate to induce differentiation and inhibit proliferation of leukemic cells (FDA label, NCI Thesaurus).

Key Inclusion

  • Age ≥ 18 years
  • Relapsed and/or refractory Acute Myeloid Leukemia with documented IDH1 mutation
  • No more than 2 lines of prior therapy, one must have contained venetoclax
  • ECOG Performance Status ≤ 2
  • Creatinine clearance ≥ 30 mL/min
  • Total bilirubin ≤ 2× ULN (≤ 3× ULN in Gilbert Syndrome)
  • AST and ALT ≤ 5× ULN
  • Negative pregnancy test for childbearing potential

Key Exclusion

  • Previous exposure to ivosidenib or any IDH1 inhibitor
  • Active infection requiring IV systemic therapy
  • Known CNS involvement with AML
  • Allogeneic stem cell transplant within 60 days
  • Investigational drug within 21 days or 2 half-lives
  • Pregnant or breastfeeding
  • Concomitant use of strong or moderate CYP3A inducers
  • Concomitant use of sensitive CYP3A substrates