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Monthly Update Report - October 2025


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Important Notice:
Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. This report is not a substitute for professional medical advice, diagnosis, or treatment.

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


Overview

Number of Trials: 25

These 25 trials span hematologic malignancies (lymphomas, leukemias, myeloid neoplasms) and one pancreatic neuroendocrine tumor study. Most focus on relapsed/refractory disease using novel agents (CAR-T, bispecific antibodies, targeted inhibitors, immunomodulators) or optimized chemotherapy regimens. Several trials test experimental combinations (e.g., venetoclax + ibrutinib, pembrolizumab + chemotherapy, CAR-T with IL-7 support). Pediatric and adult populations are represented, with emphasis on personalized approaches (ctDNA monitoring, MRD-guided therapy, genomic profiling). Trials prioritize safety, efficacy, and biomarker-driven decision-making.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years (adult trials); pediatric trials include ages 1 month to 30 years
  • Histologically confirmed diagnosis (lymphoma, leukemia, or myeloid neoplasm)
  • Measurable or assessable disease by imaging or bone marrow
  • ECOG/Karnofsky/Lansky performance status ≥50–70%
  • Adequate organ function: ANC ≥1000/µL, platelets ≥50,000–100,000/µL, bilirubin ≤1.5–3× ULN, AST/ALT ≤3–5× ULN, creatinine clearance ≥30–60 mL/min
  • Negative pregnancy test for women of childbearing potential
  • Willingness to use contraception during and after treatment
  • Informed consent and ability to comply with study procedures

Common Exclusion

  • Active uncontrolled infection (bacterial, viral, fungal)
  • Pregnant or breastfeeding
  • Prior allogeneic stem cell transplant (in some trials)
  • Active CNS involvement by malignancy (in most trials)
  • Significant cardiac dysfunction (NYHA Class III/IV, LVEF <40–50%)
  • Uncontrolled autoimmune disease requiring immunosuppression
  • HIV with detectable viral load or CD4 <200–350/µL
  • Active hepatitis B or C with detectable viral load
  • Prior hypersensitivity to study agents
  • Concurrent other malignancy (within 2–3 years)
  • Receipt of live vaccines within 4 weeks
  • Use of strong CYP3A inhibitors/inducers (for trials with venetoclax, ibrutinib)

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


NCT07021989

Pembrolizumab and GVD With ctDNA-guided Consolidation in Patients With Relapsed or Refractory Classic Hodgkin Lymphoma: A Multicenter Phase 2 Study of the University of California Hematologic Malignancies Consortium Genomic-based

Organization/Sponsor: University of California, San Francisco


Example patient: A 42-year-old with relapsed nodular sclerosis Hodgkin lymphoma after ABVD chemotherapy, ECOG status 1, with a 2 cm FDG-avid mediastinal mass and adequate organ function.

Phase 2

Interventions

  • Diagnostic Test: Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computerized tomography (CT)
    Summary: FDG PET/CT detects cancer cells by showing areas of high glucose metabolism, used to stage and assess lymphoma treatment response and guide therapy (Web Search).
  • Biological: Pegfilgrastim
    Summary: Pegfilgrastim is a long-acting pegylated G-CSF that stimulates neutrophil production by binding G-CSF receptors, reducing infection risk during myelosuppressive chemotherapy (FDA label, NCI Thesaurus).
  • Diagnostic Test: Foresight CLARITY™ LDT
    Summary: Foresight CLARITY™ LDT is a liquid biopsy platform using next-generation sequencing to measure circulating tumor DNA for minimal residual disease detection in lymphoma (Web Search).
  • Drug: Liposomal Doxorubicin
    Summary: Liposomal doxorubicin delivers doxorubicin selectively to cancer cells, intercalating DNA and inhibiting topoisomerase II to induce apoptosis with reduced cardiotoxicity (Web Search).
  • Drug: Vinorelbine
    Summary: Vinorelbine is a microtubule-targeting chemotherapy agent that disrupts mitosis and induces apoptosis in cancer cells, used in lymphoma treatment (Web Search).
  • Drug: Gemcitabine
    Summary: Gemcitabine is a nucleoside analog that inhibits DNA synthesis by incorporating into DNA and inhibiting ribonucleotide reductase, disrupting cancer cell replication (FDA label, NCI Thesaurus).
  • Radiation: Non-investigational, involved site radiotherapy (ISRT)
    Summary: ISRT targets specific lymphoma sites with radiation, minimizing normal tissue exposure using intensity-modulated techniques to treat localized disease (Web Search).
  • Biological: Pembrolizumab
    Summary: Pembrolizumab is a humanized anti-PD-1 monoclonal antibody that blocks PD-1/PD-L1 interaction, enhancing T-cell-mediated immune responses against tumors including classical Hodgkin lymphoma (FDA label, NCI Thesaurus).

Key Inclusion

  • Age ≥ 18 years
  • Histologically confirmed classic Hodgkin lymphoma
  • Relapsed or refractory disease after no more than one line of systemic therapy including doxorubicin
  • At least one FDG-avid lesion ≥ 1.5 cm (nodal) or ≥ 1.0 cm (extranodal)
  • ECOG performance status 0-2
  • Adequate organ function (ANC ≥ 1.0 × 10^9/L, platelets ≥ 75 × 10^9/L, bilirubin ≤ 1.5× ULN, AST/ALT ≤ 3× ULN, CrCl ≥ 40 mL/min)
  • Negative pregnancy test for females of reproductive potential within 72 hours before treatment
  • HIV-positive individuals eligible if on effective antiretroviral therapy with undetectable viral load

Key Exclusion

  • Prior PD-1 inhibitor-based regimen with progression within 6 months of last dose
  • Systemic anti-cancer therapy or radiation within 2 weeks or antibody therapy within 4 weeks
  • Prior autologous or allogeneic hematopoietic stem cell transplant
  • Systemic autoimmune disease requiring continuous immunosuppression (≥ prednisone 10 mg/day)
  • Left ventricular ejection fraction < 50%
  • Lifetime cumulative doxorubicin dose would exceed 450 mg/m² after 4 cycles (> 330 mg/m² at entry)
  • Known hypersensitivity to pembrolizumab, gemcitabine, vinorelbine, or liposomal doxorubicin
  • Pregnant or breastfeeding individuals

NCT07044544

A Phase I Trial to Evaluate the Safety and Efficacy of Addition of Novel Anti-leukemia Agents to Flu/Mel RIC Transplant for High-risk Myeloid Malignancies Genomic-based

Organization/Sponsor: University of Alabama at Birmingham


Example patient: A 62-year-old male with therapy-related AML in first complete remission with minimal residual disease positivity, Karnofsky score 80, with a matched unrelated donor available for reduced intensity transplant.

Phase 1

Interventions

  • Drug: Venetoclax
    Summary: Venetoclax is a selective BCL-2 inhibitor that restores programmed cell death in cancer cells by binding to BCL-2 proteins and repressing their anti-apoptotic activity. FDA-approved for CLL, SLL, and newly diagnosed AML in combination with hypomethylating agents. Sources: FDA label, NCI Thesaurus, Web Search.
  • Drug: Decitabine
    Summary: Decitabine is a nucleoside metabolic inhibitor that induces DNA hypomethylation by inhibiting DNA methyltransferase, causing intra-S-phase arrest and restoring normal blood cell production. FDA-approved for myelodysplastic syndromes. Sources: FDA label, NCI Thesaurus, Web Search.
  • Biological: G-CSF
    Summary: G-CSF stimulates neutrophil production in bone marrow and promotes their release into circulation, reducing infection risk by boosting white blood cell counts during chemotherapy. Source: Web Search.

Key Inclusion

  • Age 18-75 years
  • Related or unrelated peripheral blood stem cell donor with HLA matching
  • Candidate for reduced intensity preparative regimen (age ≥60 or HCT-CI ≥4)
  • AML with active disease, adverse risk, MRD+ intermediate risk, or CR2 or beyond
  • MDS with IPSS-M ≥ high and/or ≥5% blasts
  • MDS/MPN >5% blasts and spleen < 22 cm
  • Karnofsky performance status ≥70
  • Ejection fraction >40%, creatinine clearance >50 mL/min, DLCO and FEV1 ≥50%

Key Exclusion

  • Previous allogeneic stem cell transplant
  • Autologous transplant < 3 months prior
  • Uncontrolled angina or severe ventricular arrhythmias
  • Known hypersensitivity to Decitabine, Venetoclax, or ATG
  • Pregnant or breastfeeding
  • HIV positive serology
  • Current uncontrolled bacterial, viral, or fungal infection
  • Documented cirrhosis

NCT06898905

Hyperfractionated Dual Equivalent Fractionated (HyDEF) Bridging Radiation Therapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Undergoing T-Cell Redirection Therapy

Organization/Sponsor: Yale University


Example patient: A 52-year-old man with relapsed DLBCL and a 7 cm abdominal mass, ECOG status 1, scheduled for CAR-T therapy at Yale, able to attend twice-daily radiation sessions.

Phase N/A

Interventions

  • Radiation: Bridging Radiation Therapy
    Summary: Bridging radiation therapy targets tumor sites to reduce tumor burden before CAR-T cell or bispecific antibody therapy in relapsed/refractory B-cell lymphoma, preparing patients for subsequent T-cell redirection treatment without significant toxicity (Web Search).

Key Inclusion

  • Histologically confirmed R/R DLBCL
  • Tumor size ≥5 cm in greatest dimension
  • Plan for CAR T or BsAb therapy at Yale New Haven Hospital
  • ECOG performance status 0 to 3
  • Age ≥18 years
  • Ability to present for twice daily fractionated radiation therapy
  • No contraindications for radiotherapy

Key Exclusion

  • Pregnant or breastfeeding
  • Prior radiation exposure for research within past year exceeding FDA limits
  • Unable to safely receive FDG PET tracer
  • Unable to participate in twice daily radiotherapy
  • Clinical contraindications to radiation therapy
  • Would not derive clinical benefit from bridging radiotherapy

NCT06817720

Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase Genomic-based

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 45-year-old man with newly diagnosed Ph-positive CML in early chronic phase (6 months from diagnosis), ECOG status 1, adequate organ function, and no prior TKI therapy beyond 2 weeks.

Phase II

Interventions

  • Drug: olverembatinib
    Summary: Third-generation BCR-ABL1 tyrosine kinase inhibitor targeting chronic myeloid leukemia, including T315I mutation-resistant cases, used for treatment-resistant disease (Web Search).

Key Inclusion

  • Age ≥18 years
  • Ph-positive or BCR::ABL1 positive CML in early chronic phase
  • Time from diagnosis to therapy ≤12 months
  • Prior TKI for ≤30 days allowed
  • ECOG performance status ≤2
  • Adequate organ function (bilirubin ≤1.5x ULN, transaminases ≤3x ULN, creatinine clearance ≥30 mL/min)
  • Additional chromosomal abnormalities at diagnosis without accelerated phase criteria eligible
  • Contraception required during study and 4 months after

Key Exclusion

  • More than 30 days of prior FDA-approved TKI
  • Late chronic phase (>12 months from diagnosis), accelerated phase, or blast phase CML
  • NYHA cardiac class 3-4 heart disease or prolonged QTc >460 msec
  • Uncontrolled angina, ventricular arrhythmias, or congenital long QT syndrome
  • Active uncontrolled infection or detectable HBV/HCV viral load on treatment
  • Pregnant or breastfeeding
  • Uncontrolled psychiatric disorders or cognitive impairment limiting compliance
  • Significant bleeding disorder unrelated to cancer

NCT06918431

A Phase 2 Study Evaluating the Safety and Efficacy of Asparaginase Erwinia Chrysanthemi- Recombinant-Rywn (Recombinant Erwinia Asparaginase) During Pediatric-Inspired Regimen in High-Risk Adults With Newly Diagnosed ALL or LBL Genomic-based

Organization/Sponsor: City of Hope Medical Center


Example patient: A 35-year-old obese male with newly diagnosed B-cell acute lymphoblastic leukemia, ECOG status 1, normal cardiac function, no prior chemotherapy, and CD20-positive disease with white blood cell count of 18,000.

Phase 2

Interventions

  • Drug: Asparaginase Erwinia chrysanthemi
    Summary: Enzyme that depletes asparagine, an amino acid essential for cancer cell growth, used to treat acute lymphoblastic leukemia and lymphoblastic lymphoma, particularly in patients resistant to traditional asparaginase (Summary of Web Search).
  • Drug: Vincristine Sulfate
    Summary: Chemotherapy agent that disrupts microtubule function to inhibit cancer cell division, commonly used in leukemia and lymphoma treatments (Summary of Web Search).
  • Drug: Rituximab
    Summary: Chimeric monoclonal antibody targeting CD20 antigen on B cells, inducing cell death via antibody-dependent cytotoxicity for CD20-positive B-cell malignancies including non-Hodgkin lymphoma and chronic lymphocytic leukemia (FDA label, NCI Thesaurus).
  • Drug: Methotrexate
    Summary: Dihydrofolate reductase inhibitor that blocks folate-dependent enzymes, suppressing DNA and RNA synthesis, particularly effective in acute lymphoblastic leukemia (FDA label, Summary of Web Search).
  • Drug: Mercaptopurine
    Summary: Antimetabolite targeting rapidly dividing cells, used in acute lymphoblastic leukemia chemotherapy, often as part of combination regimens (Summary of Web Search).
  • Drug: Dexamethasone
    Summary: Corticosteroid that suppresses inflammation and modulates immune response, used in leukemia and lymphoma treatment protocols (Summary of Web Search).
  • Drug: Daunorubicin Hydrochloride
    Summary: Anthracycline chemotherapy agent that inhibits DNA synthesis in rapidly dividing cancer cells, especially used in acute myeloid leukemia, often in combination therapy (Summary of Web Search).
  • Drug: Cytarabine
    Summary: Nucleoside metabolic inhibitor that interferes with DNA synthesis during S phase, used to treat acute leukemias via intravenous, subcutaneous, or intrathecal administration (FDA label, NCI Thesaurus).
  • Drug: Cyclophosphamide
    Summary: Alkylating agent that binds to DNA disrupting replication, used for lymphomas, leukemias, and solid tumors with immunosuppressive properties (FDA label, NCI Thesaurus).
  • Procedure: Lumbar Puncture
    Summary: Invasive procedure to access cerebrospinal fluid for cancer diagnosis or intrathecal chemotherapy administration, crucial for detecting CNS involvement in leukemia (Summary of Web Search, NCI Thesaurus).
  • Procedure: Bone Marrow Biopsy
    Summary: Diagnostic procedure removing bone marrow core tissue to evaluate hematopoietic disorders, determine leukemia or lymphoma type, stage, and treatment response (Summary of Web Search, NCI Thesaurus).
  • Procedure: Bone Marrow Aspiration
    Summary: Procedure extracting immature hematopoietic elements from bone marrow for microscopic analysis to assess disease extent in leukemia and lymphoma (Summary of Web Search, NCI Thesaurus).
  • Diagnostic Test: Positron Emission Tomography
    Summary: Imaging technique detecting metabolic activity using positron-emitting radionuclides to assess treatment response and disease progression in lymphoma and leukemia (Summary of Web Search, NCI Thesaurus).
  • Diagnostic Test: Echocardiography
    Summary: Ultrasound imaging of heart structures to monitor cardiac function, required for baseline assessment before cardiotoxic chemotherapy agents (Summary of Web Search, NCI Thesaurus).
  • Diagnostic Test: Computed Tomography
    Summary: X-ray imaging technique creating cross-sectional scans to monitor disease progression and treatment response in leukemia and lymphoma (Summary of Web Search, NCI Thesaurus).
  • Other: Biospecimen Collection
    Summary: Collection of tissue or fluid samples for research purposes to study genetic features and disease patterns in cancer (Summary of Web Search, NCI Thesaurus).

Key Inclusion

  • Age 18-39 with BMI ≥30 or age 40-54 regardless of BMI
  • Newly diagnosed Philadelphia-negative acute lymphoblastic leukemia or lymphoblastic lymphoma
  • Both B-cell and T-cell phenotypes allowed
  • ECOG performance status ≤2
  • Left ventricular ejection fraction ≥50%
  • Creatinine clearance ≥60 mL/min
  • CD20+ patients: WBC <25 x 10^9/L prior to rituximab
  • Adequate liver function: bilirubin ≤1.5x ULN, AST/ALT ≤3x ULN

Key Exclusion

  • Philadelphia chromosome positive (Ph+) leukemia
  • Prior leukemia chemotherapy except cytoreduction or ATRA
  • Previous treatment with any asparaginase formulation
  • Parenchymal CNS involvement
  • History of grade ≥3 pancreatitis
  • Class III/IV cardiovascular disability or recent cardiac ischemic event
  • History of intracranial thrombosis or recurrent thrombosis
  • Pregnant or breastfeeding

NCT05779930

Safety and Feasibility of On-Site Manufacture of CD19 CAR T Cells Using the CliniMACS Prodigy in Pediatric and Young Adult Patients With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma Genomic-based

Organization/Sponsor: Nationwide Children's Hospital


Example patient: A 12-year-old with relapsed B-cell ALL in third relapse, CD19-positive disease by flow cytometry, Lansky score 60, adequate organ function, and no active infections or prior CAR T therapy.

Phase N/A

Interventions

  • Biological: CD19 specific Chimeric Antigen Receptor T Cell
    Summary: Autologous or allogeneic T-lymphocytes genetically modified to express a chimeric antigen receptor targeting CD19-positive cancers, particularly pediatric B-ALL and lymphomas. The therapy reprograms patient T cells to attack CD19-expressing cancer cells. Sources: NCI Thesaurus, Web Search.

Key Inclusion

  • Relapsed or refractory pediatric B-Cell ALL (second or greater relapse, post-allogeneic SCT relapse, or persistent MRD)
  • Relapsed or refractory pediatric B-cell non-Hodgkin's Lymphoma refractory to second-line or later therapy
  • CD19 tumor expression demonstrated by flow cytometry or biopsy
  • Age 0 to 30 years at initial diagnosis
  • Karnofsky or Lansky performance status ≥50
  • eGFR ≥60 mL/min, bilirubin ≤2 mg/dl, ALT/AST ≤5x ULN
  • Left ventricular ejection fraction ≥40%
  • Pulse oxygenation >91% on room air

Key Exclusion

  • Acute or ongoing neurologic toxicity >Grade 1
  • Active untreated infection
  • Concomitant genetic syndrome (Fanconi anemia, Kostmann, Shwachman) except Down Syndrome
  • Grade 2-4 acute or extensive chronic GVHD
  • Pregnant or nursing women
  • Active or latent hepatitis B, active hepatitis C, or HIV positive
  • Allogeneic HSCT within 3 months of enrollment
  • Any prior CD19 CAR T cell therapy

NCT07223021

Improving EveNt Free Survival by Optimizing FLUdarabine Exposure During LymphodepletioN for CAR T CEll Therapy: a Randomized, Multi-center Study of Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (INFLUENCE)

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 12-year-old child weighing 35 kg with relapsed B-cell acute lymphoblastic leukemia, Lansky score of 70%, normal cardiac and renal function, and no active infections, eligible for commercial tisagenlecleucel CAR-T therapy.

Phase N/A

Interventions

  • Biological: Tisagenlecleucel (CAR-T)
    Summary: CAR-T therapy uses engineered T-cells to target CD19 on B-cell leukemia and lymphoma cells, inducing immune-mediated cancer cell death. Used for relapsed/refractory B-ALL in this trial. Source: Summary of Web Search.
  • Drug: Fludarabine
    Summary: Fludarabine is a fluorinated nucleoside analog that inhibits DNA synthesis by disrupting DNA polymerase and ribonucleotide reductase. Used for lymphodepletion prior to CAR-T therapy. Sources: FDA label, NCI Thesaurus, Summary of Web Search.
  • Drug: Cyclophosphamide
    Summary: Cyclophosphamide is an alkylating agent that binds DNA and inhibits replication, causing cell death. Used for lymphodepletion in combination with fludarabine before CAR-T infusion. Sources: FDA label, NCI Thesaurus, Summary of Web Search.

Key Inclusion

  • B-cell acute lymphoblastic leukemia (B-ALL) eligible for commercial tisagenlecleucel
  • Patient weight >9 kg at lymphodepleting chemotherapy
  • Serum bilirubin ≤2 mg/dL
  • Calculated GFR ≥70 ml/min/1.73m²
  • LVEF ≥50% by MUGA, echocardiogram, or cardiac MRI
  • Oxygen saturation ≥90% on room air
  • ECOG ≤1 or Karnofsky >60% (age ≥16 years); Lansky ≥60% (age <16 years)
  • Written informed consent from parents/legal representative and age-appropriate assent

Key Exclusion

  • Known hypersensitivity to fludarabine, cyclophosphamide, or tisagenlecleucel
  • Tisagenlecleucel deemed out of specification (OOS)
  • Clinically significant active and uncontrolled infection
  • Unable to give informed consent or comply with treatment protocol
  • Pregnant or lactating women

NCT07198087

A Phase 1, Open-Label, Parallel-Group Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants

Organization/Sponsor: Ono Pharmaceutical Co. Ltd


Example patient: A 52-year-old male with stable Child-Pugh Class B hepatic impairment, BMI 28 kg/m2, eGFR 60 mL/min, no encephalopathy, and adequate bone marrow function.

Phase 1

Interventions

  • Drug: Tirabrutinib
    Summary: Tirabrutinib is a BTK inhibitor that targets Bruton's tyrosine kinase to inhibit B-cell proliferation, used in clinical trials for B-cell lymphoma and chronic lymphocytic leukemia with promising efficacy and manageable safety profile (Web Search).

Key Inclusion

  • Age 18 to 75 years
  • BMI between 18 and 40 kg/m2
  • eGFR of 45 mL/minute or higher
  • Chronic and stable hepatic impairment Child-Pugh classification A, B, or C
  • Adequate bone marrow, renal, and hepatic function
  • Healthy participants matched to hepatic impairment participants by sex, BMI and age
  • Willingness to swallow study tablets
  • Continuous non-smokers or smokers of 20 cigarettes or fewer per day

Key Exclusion

  • History of liver transplant
  • Hepatic encephalopathy Grade 2 or above
  • History of stroke or intracranial hemorrhage within 6 months
  • History of bleeding diathesis
  • Positive HIV results
  • ALT or AST ≥3 × ULN
  • QTcF >450 ms
  • Receipt of CYP3A4 inducers or strong inhibitors within 14 days

NCT06649812

A Phase 2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse-Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2) Genomic-based

Organization/Sponsor: National Cancer Institute (NCI)


Example patient: A 52-year-old man with relapsed CD10-negative non-GCB DLBCL after R-CHOP chemotherapy, ECOG status 1, with measurable lymphadenopathy and adequate organ function, no prior venetoclax or ibrutinib exposure.

Phase 2

Interventions

  • Drug: Venetoclax
    Summary: Venetoclax is a selective BCL-2 inhibitor that induces apoptosis in cancer cells by blocking BCL-2 protein, approved for CLL, SLL, and AML; it restores programmed cell death in tumor cells overexpressing BCL-2 (FDA label, NCI Thesaurus).
  • Drug: Ibrutinib
    Summary: Ibrutinib is a Bruton tyrosine kinase (BTK) inhibitor that irreversibly blocks BTK activity, preventing B-cell activation and signaling, indicated for CLL, SLL, Waldenström's macroglobulinemia, and chronic GVHD (FDA label, NCI Thesaurus).
  • Drug: Lenalidomide
    Summary: Lenalidomide is a thalidomide analog immunomodulatory agent with antiangiogenic and antineoplastic properties, indicated for multiple myeloma, MDS with del(5q), and relapsed/refractory mantle cell lymphoma; it inhibits TNF-alpha, stimulates T cells, and reduces VEGF (FDA label, NCI Thesaurus).
  • Drug: Obinutuzumab
    Summary: Obinutuzumab is a glycoengineered humanized anti-CD20 monoclonal antibody that induces enhanced antibody-dependent cellular cytotoxicity (ADCC) and direct apoptosis in CD20-expressing B cells, indicated for CLL and follicular lymphoma (FDA label, NCI Thesaurus).
  • Drug: Prednisone
    Summary: Prednisone is a synthetic glucocorticoid that binds nuclear receptors to inhibit proinflammatory cytokines, decrease circulating lymphocytes, and induce apoptosis in sensitive tumor cells, used for inflammatory and neoplastic conditions (FDA label, NCI Thesaurus).
  • Procedure: Biopsy Procedure
    Summary: Tissue removal for microscopic examination to establish diagnosis; includes tumor biopsies for molecular analysis and bone marrow biopsies to diagnose and assess leukemia and lymphoma (NCI Thesaurus, Web Search).
  • Procedure: Bone Marrow Aspiration
    Summary: Aspiration of immature hematopoietic elements from bone marrow for evaluation of hematopoietic disorders, infectious diseases, and cytogenetic studies in leukemia and lymphoma (NCI Thesaurus, Web Search).
  • Procedure: Bone Marrow Biopsy
    Summary: Removal of core tissue containing bone spicules and marrow stroma for diagnosis and evaluation of hematopoietic neoplasms and staging of solid tumors and lymphomas (NCI Thesaurus, Web Search).
  • Procedure: Biospecimen Collection
    Summary: Collection of blood, tissue, or fluid samples for research, testing, and diagnostic purposes to identify genetic changes and disease mechanisms in leukemia and lymphoma (NCI Thesaurus, Web Search).
  • Diagnostic Test: Positron Emission Tomography
    Summary: Imaging technique measuring gamma radiation from positron-electron collisions to detect metabolic activity in cancer cells, used to assess lymphoma treatment response and disease progression (NCI Thesaurus, Web Search).
  • Diagnostic Test: Computed Tomography
    Summary: X-ray imaging method using computer reconstruction to create cross-sectional scans for visualizing tumors, staging disease, and monitoring progression in leukemia and lymphoma (NCI Thesaurus, Web Search).
  • Diagnostic Test: Magnetic Resonance Imaging
    Summary: Imaging using radiofrequency waves and magnetic fields to visualize tumors, monitor treatment effects, and assess disease in cancer patients including lymphoma (NCI Thesaurus, Web Search).

Key Inclusion

  • Age ≥18 years
  • Histologically confirmed aggressive B-cell lymphoma (CD10-negative DLBCL or HGBCL with MYC and BCL2 rearrangements)
  • Relapsed/refractory disease after ≥1 prior anthracycline and anti-CD20 antibody-containing regimen
  • Measurable disease
  • ECOG performance status 0-2
  • Adequate bone marrow function (ANC ≥1000/mcL, platelets ≥75,000/mcL, hemoglobin ≥8 g/dL)
  • Adequate organ function (creatinine clearance ≥30 mL/min, bilirubin ≤1.5x ULN, AST/ALT ≤3x ULN)
  • Adequate FFPE tumor tissue for molecular analysis

Key Exclusion

  • Primary mediastinal large B-cell lymphoma (PMBL)
  • Primary or suspected CNS lymphoma (PCNSL)
  • More than 3 prior lines of cytotoxic chemotherapy
  • Previous treatment with more than one study agent (venetoclax, ibrutinib, or lenalidomide)
  • Prior ASCT, CAR-T, or allogeneic transplant within 3 months
  • Active graft-versus-host disease or immunosuppressants within 28 days
  • Pregnancy or breastfeeding
  • Uncontrolled intercurrent illness or active infection

NCT06176690

Constitutive IL7R (C7R) Modified Banked Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes (CD30.CAR-EBVSTs) in Patients With Relapsed or Refractory CD30-Positive Lymphomas

Organization/Sponsor: Baylor College of Medicine


Example patient: A 28-year-old with relapsed Hodgkin lymphoma confirmed CD30-positive by pathology, Karnofsky score 70%, normal organ function, who completed brentuximab vedotin 6 weeks ago and is not on corticosteroids.

Phase N/A

Interventions

  • Biological: C7R.CD30.CAR-EBVST cells
    Summary: Allogeneic EBV-specific T-lymphocytes genetically modified with a CAR targeting CD30 and constitutive IL7R for enhanced persistence. Recognizes and lyses CD30-expressing tumor cells in hematologic malignancies including Hodgkin lymphoma and peripheral T-cell lymphomas. Source: NCI Thesaurus.

Key Inclusion

  • CD30-positive tumor confirmed in CLIA certified laboratory
  • Hodgkin lymphoma, CD30+ aggressive B-cell lymphoma, or peripheral T-cell lymphoma
  • Age 12 to 75 years
  • Karnofsky or Lansky score >60%
  • Estimated GFR >70 mL/min
  • Bilirubin ≤2x upper limit of normal (≤3x for Gilbert syndrome)
  • AST <3x upper limit of normal
  • Pulse oximetry >90% on room air

Key Exclusion

  • Received investigational cell therapy or vaccine within 6 weeks
  • Received CD30 antibody-based therapy within 4 weeks
  • Tumor location where enlargement could cause airway obstruction
  • Systemic corticosteroids ≥10 mg/day prednisone equivalent
  • Symptomatic cardiac disease (NYHA Class III or IV)
  • Active uncontrolled bacterial, viral, or fungal infection
  • History of hypersensitivity to murine protein products
  • Pregnant or lactating

NCT07070219

A Single-Arm, Open-Label, Multi-Center, Phase 1b/ 2 Study to Evaluate the Safety, Efficacy, and Cellular Pharmacokinetic Profile of CTD402 in Participants With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and Lymphoblastic Lymphoma (T-LBL) (TENACITY-01)

Organization/Sponsor: BIOHENG THERAPEUTICS US LLC


Example patient: A 15-year-old with relapsed T-ALL after three prior therapies, bone marrow blasts at 12%, Karnofsky score 70, with an available haploidentical donor and no active infections.

Phase 1b, Phase 2

Interventions

  • Biological: CTD402 CAR T Cell Injection
    Summary: Allogeneic, off-the-shelf, universal CAR-T cells targeting CD7 with CD7 knockout and HLA class II disruption to prevent fratricide and immune rejection. Expresses anti-CD7 CAR with 4-1BB and CD3 zeta domains for treating CD7-positive T-cell malignancies including T-ALL and T-LBL. Source: NCI Thesaurus.

Key Inclusion

  • Age ≥12 years
  • Body weight ≥40 kg
  • Relapsed/refractory T-ALL/LBL after ≥2 lines of therapy or first relapse within 12 months
  • Bone marrow lymphoblasts ≥5% or extramedullary disease
  • Eligible HLA-matched, haploidentical, or syngeneic donor available
  • Adequate organ function
  • Karnofsky PS ≥60 (age ≥16) or Lansky PS ≥60 (age <16)

Key Exclusion

  • Genetic syndromes with bone marrow failure
  • Active CNS involvement
  • NYHA class III/IV heart failure or recent cardiac events within 12 months
  • Primary immune deficiency
  • Uncontrolled infections
  • HIV, hepatitis C, or syphilis infection
  • Active or latent hepatitis B
  • EBV, CMV DNA or IgM positive at screening

NCT06710418

Red Blood Cell Transfusion Threshold-Specific Bleeding, Quality of Life and Functional Outcomes in Acute Leukemia Patients With Thrombocytopenia: a Randomized Feasibility Study

Organization/Sponsor: University of Washington


Example patient: A 45-year-old man with newly diagnosed AML with 25% bone marrow blasts, scheduled for 7+3 induction chemotherapy at UW, with no recent thrombotic events or bleeding complications.

Phase N/A

Interventions

  • Procedure: Packed Red Blood Cell Transfusion
    Summary: Packed red blood cell transfusion increases hemoglobin levels to improve oxygen delivery in patients with severe anemia from chemotherapy, aiming to maintain hemoglobin thresholds and enhance quality of life (Summary of Web Search).
  • Other: Quality-of-Life Assessment
    Summary: Quality-of-life assessment measures physical, social, and emotional well-being using standardized tools like EORTC QLQ-C30, evaluating symptoms and treatment impact in leukemia and lymphoma patients (Summary of Web Search, NCI Thesaurus).
  • Other: Electronic Health Record Review
    Summary: Electronic health record review analyzes EHR data to assess patient eligibility and facilitate efficient trial matching and recruitment for leukemia and lymphoma patients (Summary of Web Search, NCI Thesaurus).
  • Other: Cognitive Assessment
    Summary: Cognitive assessment uses structured cognitive exercises and interventions like cognitive behavioral therapy to address cancer-related cognitive impairment and enhance mental function in leukemia and lymphoma patients (Summary of Web Search).
  • Other: Biospecimen Collection
    Summary: Biospecimen collection involves obtaining tissue or fluid samples for research to study genetic features and disease patterns in cancer patients (Summary of Web Search, NCI Thesaurus).
  • Other: Activity Tracking
    Summary: Activity tracking monitors and encourages physical activity levels during lymphoma treatment to improve patient well-being and manage treatment side effects (Summary of Web Search).

Key Inclusion

  • Age ≥ 18 years
  • High-grade myeloid neoplasm (≥10% blasts) or AML (excluding APL) or B-cell ALL per 2022 WHO classification
  • Plan for intensive chemotherapy induction or post-remission therapy or allogeneic HSCT
  • Expected anemia requiring PRBC transfusion and platelet counts ≤30,000/uL for ≥5 days
  • Post-treatment care at UW/FHCC
  • Ability to provide written informed consent

Key Exclusion

  • Prophylactic platelet transfusion threshold >10,000/uL
  • Systemic anticoagulation, anti-platelet, or antifibrinolytic therapy not held when platelets <50,000/uL
  • Grade ≥2 bleeding at randomization per WHO Bleeding Criteria
  • Arterial or venous thrombotic event or myocardial infarction within 6 months
  • Renal replacement therapy at randomization
  • Decline transfusion for personal or religious beliefs
  • Pregnancy or lactation

NCT07130695

Olutasidenib Single Agent as Maintenance Therapy in IDH1mut AML After Induction and Consolidation Genomic-based

Organization/Sponsor: Virginia Commonwealth University


Example patient: A 52-year-old man with IDH1-mutant AML who achieved complete remission after intensive induction and consolidation chemotherapy 45 days ago, with ECOG status 1 and adequate organ function, seeking maintenance therapy.

Phase N/A

Interventions

  • Drug: Olutasidenib
    Summary: Olutasidenib is an oral IDH1 inhibitor that targets IDH1 mutations in acute myeloid leukemia, blocking mutant enzyme function and promoting differentiation. It is administered as capsules and has shown efficacy in relapsed/refractory AML (Source: Web Search).

Key Inclusion

  • IDH1 mutant acute myeloid leukemia (non-APL)
  • Completed induction/consolidation with CR, CRh, CRi, or MLFS
  • Within 90 days of last upfront therapy cycle
  • Age ≥18 years
  • Creatinine clearance ≥30 mL/min
  • ECOG 0-2 or KPS >50%
  • Able to take oral medications
  • Adequate liver function (bilirubin ≤2× ULN, AST/ALT ≤3× ULN)

Key Exclusion

  • Received non-intensive upfront therapy (HMA/Venetoclax based)
  • Currently receiving other AML-directed or targeted therapies
  • Stem cell transplant planned within 60 days
  • QTc >450 ms or history of Torsades de Pointes
  • Hypersensitivity to olutasidenib
  • Gastrointestinal condition impairing oral absorption
  • Pregnant or nursing women
  • Systemic corticosteroids above 10mg/day prednisone equivalent

NCT07109219

A Modular Phase I/II, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AZD4512 Monotherapy or in Combination With Anticancer Agent(s) in Participants With Acute Lymphoblastic Leukemia Genomic-based

Organization/Sponsor: AstraZeneca


Example patient: A 14-year-old with CD22-positive Philadelphia chromosome-negative B-ALL who relapsed after two prior chemotherapy regimens, has bone marrow blasts of 15%, ECOG performance status of 1, and completed allogeneic stem cell transplant 16 weeks ago.

Phase 1, Phase 2

Interventions

  • Drug: AZD4512 monotherapy
    Summary: AZD4512 is a targeted therapy for CD22-positive B-cell acute lymphoblastic leukemia targeting specific molecular pathways; ongoing clinical trials assess efficacy and safety in pediatric and adult populations (Web Search).

Key Inclusion

  • Age 12-16 years or older depending on module
  • CD22-positive B-ALL diagnosis per WHO criteria
  • Relapsed or refractory B-ALL with bone marrow blasts >5% or peripheral blood blasts
  • ECOG ≤2 or KPS ≥50 or LPS ≥50
  • Peripheral lymphoblast count <10,000/µL
  • At least 2 prior therapies with relapse/refractoriness or 1 prior therapy with no standard options
  • Ph+ B-ALL must be TKI intolerant or refractory to at least 2 prior TKIs
  • Prior alloHSCT >12 weeks, cell therapy/autoHSCT >8 weeks, DLI >4 weeks

Key Exclusion

  • Burkitt lymphoma or leukemia
  • Isolated extramedullary disease or active testicular/CNS involvement (>CNS1)
  • Unresolved non-hematologic toxicities Grade ≥2 except specified exceptions
  • History of drug-induced ILD/pneumonitis requiring steroids or oxygen
  • Cytotoxic treatment within 14 days except maintenance or cytoreduction
  • Biologic/immuno-oncology treatment within 28 days or 5 half-lives
  • Strong CYP3A4 inhibitors within 21 days or 5 half-lives
  • Medications prolonging QTc or associated with Torsades de Pointes within 21 days or 5 half-lives

NCT06796998

Phase 2 Trial of Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)

Organization/Sponsor: University of Miami


Example patient: A 62-year-old treatment-naive woman with stage III extranodal marginal zone lymphoma involving multiple sites with measurable disease >3 cm, experiencing night sweats and weight loss, with adequate organ function and no prior systemic therapy.

Phase 2

Interventions

  • Biologic: Epcoritamab
    Summary: CD3xCD20 T-cell engaging bispecific antibody that targets CD20 on B-cells and CD3 on T-cells, promoting T-cell-mediated killing of B-cells for treating relapsed/refractory lymphomas (Source: Web Search).

Key Inclusion

  • Histologically confirmed Marginal Zone Lymphoma (EMZL, NMZL, or SMZL) stage I-IV
  • Previously untreated participants or only localized therapy with recurrent disease
  • Radiographically measurable disease ≥1.5 cm longest diameter and ≥1.0 cm perpendicular diameter
  • At least one criterion for treatment initiation (threatened organ function, ≥3 nodal sites ≥3 cm, mass ≥5 cm, B symptoms, splenomegaly, cytopenias, or leukemia)
  • Age ≥18 years
  • ECOG performance status 0-2
  • ANC ≥1.0×10^9/L, hemoglobin ≥8.0 g/dL, platelets ≥50×10^9/L
  • Creatinine clearance ≥35 mL/min or eGFR ≥30 mL/min/1.73 m2

Key Exclusion

  • Evidence of DLBCL transformation
  • History of central nervous system lymphoma (dural MZL eligible)
  • Prior anticancer therapy (chemotherapy, radiation, immunotherapy, biologic, or investigational)
  • Systemic immunosuppressive medications including prednisone >20 mg within 2 weeks
  • Prior allogeneic/autologous stem cell transplant or CAR T-cell therapy
  • Other malignancy within 3 years except specified low-risk cancers
  • Active infection requiring systemic treatment or major IV antibiotic use within 4 weeks
  • Known HIV, active hepatitis B or C, autoimmune disease, or active SARS-CoV-2 infection

NCT06520098

Benefit of Venetoclax Addition ("Benefit VA") in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Organization/Sponsor: VA Office of Research and Development


Example patient: A 65-year-old veteran with CLL on stable acalabrutinib for 8 months, ECOG 1, with persistent lymphocytosis and small lymph nodes, no cardiac disease or active infections.

Phase N/A

Interventions

  • Drug: Ibrutinib, Acalabrutinib, Zanubrutinib
    Summary: Bruton's tyrosine kinase (BTK) inhibitors that block cancer cell signaling and growth, used to treat chronic lymphocytic leukemia and lymphoma (Web Search).
  • Drug: Venetoclax
    Summary: Selective BCL-2 inhibitor that restores apoptosis in cancer cells by binding BCL-2 protein; FDA-approved for CLL/SLL and AML, does not inhibit bcl-XL (FDA label, NCI Thesaurus).

Key Inclusion

  • CLL or SLL diagnosis by 2018 IWCLL criteria
  • Currently receiving BTKi therapy for at least six months
  • Stable BTKi dose for at least three months
  • Age 18 years or older
  • ECOG performance status 0-2
  • Detectable or measurable CLL/SLL in blood or imaging
  • Low TLS risk: lymph nodes <5 cm and ALC <25 x 10^9/L
  • ANC ≥1,000/mm3 and platelets ≥30,000/mm3

Key Exclusion

  • Progression of CLL/SLL on BTKi therapy
  • Prior combination of BTKi plus venetoclax
  • History of Richter's transformation or prolymphocytic leukemia
  • Active hepatitis B or C with detectable viral load
  • NYHA Class III or IV heart failure or unstable angina
  • Active systemic anticoagulation with heparin or warfarin
  • Chronic treatment with strong CYP3A4/5 inhibitors or inducers
  • Uncontrolled active systemic infection requiring IV antibiotics

NCT06594939

Multicenter Phase II Study of Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma

Organization/Sponsor: Medical College of Wisconsin


Example patient: A 72-year-old patient with newly diagnosed CD20-positive diffuse large B-cell lymphoma Stage IV, ECOG 1, with multiple comorbidities, no prior anthracycline exposure, adequate cardiac function, and no CNS involvement.

Phase II

Interventions

  • Biologic: Mosunetuzumab
    Summary: Bispecific CD20-directed CD3 T-cell engager that binds CD20 on B-cell lymphoma cells and CD3 on T-cells, redirecting T-cells to kill cancer cells; approved for relapsed/refractory follicular lymphoma (FDA label, NCI Thesaurus).
  • Biologic: Polatuzumab Vedotin
    Summary: Antibody-drug conjugate targeting CD79B on B-cells that delivers a cytotoxic agent to kill cancer cells; used in diffuse large B-cell lymphoma (Web Search).
  • Drug: Cyclophosphamide
    Summary: Alkylating agent converted to active metabolites that bind DNA, inhibiting replication and initiating cell death; treats lymphomas, leukemias, and solid tumors (FDA label, NCI Thesaurus).
  • Drug: Doxorubicin
    Summary: Anthracycline antibiotic that intercalates DNA and inhibits topoisomerase II, preventing replication; treats various cancers but carries cardiotoxicity risk (FDA label, NCI Thesaurus).
  • Drug: Prednisone
    Summary: Synthetic glucocorticoid that binds nuclear receptors to suppress immune and inflammatory responses; used in lymphomas and autoimmune conditions (FDA label, NCI Thesaurus).
  • Biologic: Pegfilgrastim
    Summary: Long-acting pegylated G-CSF that stimulates neutrophil production by binding G-CSF receptors; reduces febrile neutropenia risk during myelosuppressive chemotherapy (FDA label, NCI Thesaurus).

Key Inclusion

  • Newly diagnosed, untreated CD20 positive diffuse large B-cell lymphoma
  • Ann Arbor Stage II bulky, III, or IV disease
  • Measurable disease by PET/CT using Lugano criteria
  • Left ventricular ejection fraction ≥50%
  • Karnofsky Performance Score ≥50 or ECOG 0-2
  • Patients aged 70-74 who are unfit or frail by CIRS-G score
  • At least one dose of COVID-19 vaccine
  • Negative SARS-CoV-2 test within 7 days prior to enrollment

Key Exclusion

  • Prior treatment for DLBCL with chemotherapy, immunotherapy, or biologic therapy
  • CNS or meningeal involvement at diagnosis
  • Primary mediastinal large B-cell lymphoma
  • Richter's Transformation from chronic lymphocytic leukemia
  • History of previous anthracycline exposure
  • Current Grade >1 peripheral neuropathy
  • Creatinine clearance <40 mL/min
  • Significant cardiovascular disease (NYHA Class III or IV)

NCT07128641

A Phase II Study of Odronextamab in Treatment Naïve Patients With Low Tumor Volume Advanced Stage Follicular Lymphoma

Organization/Sponsor: Beth Israel Deaconess Medical Center


Example patient: A 52-year-old treatment-naïve patient with CD20-positive follicular lymphoma grade 2, low tumor burden with a 2 cm cervical lymph node, normal blood counts, and no B symptoms.

Phase 2

Interventions

  • Biological: Odronextamab
    Summary: A bispecific human monoclonal antibody targeting CD20 on B-cells and CD3 on T-cells, cross-linking them to induce cytotoxic T-lymphocyte response against CD20-expressing tumor B-cells in lymphoma (NCI Thesaurus).

Key Inclusion

  • Biopsy-confirmed follicular lymphoma grade 1-3A that is CD20+ at diagnosis
  • Lymph node biopsy obtained in the previous 6 months
  • Measurable disease with at least one lymph node ≥1.5 cm long axis
  • Age ≥18 years with ECOG performance status >2 and life expectancy >2 years
  • Absolute neutrophil count ≥1000 cells/mcl, platelets ≥100,000 cells/mcl, hemoglobin ≥10 g/dL
  • Cardiac ejection fraction >40%, creatinine clearance ≥40 mL/min
  • Women of childbearing potential must use highly effective contraception for 6 months after last dose
  • Treatment naïve with no prior systemic therapy for lymphoma

Key Exclusion

  • Meets any GELF criteria for high tumor volume requiring immediate therapy
  • Any nodal or extranodal tumor mass >7 cm diameter
  • Active infection requiring treatment or uncontrolled HIV, HBV, or HCV
  • Another active malignancy in the past 2 years except specified exceptions
  • Any prior systemic therapy for lymphoma including rituximab or tazemetostat
  • Known or suspected CNS involvement or leptomeningeal disease
  • History of seizure within 12 months or neurodegenerative condition
  • Immunosuppressive therapy including corticosteroids ≥10 mg/day prednisone-equivalent within 28 days

NCT07114939

PARP-1 Targeting With the Novel Radiotracer [18F]FTT in Pancreatic Neuroendocrine Tumors

Organization/Sponsor: Abramson Cancer Center at Penn Medicine


Example patient: A 52-year-old man with metastatic grade 2 pancreatic neuroendocrine tumor with multiple liver lesions measuring up to 3 cm, currently on somatostatin analogue therapy, able to undergo PET imaging.

Phase N/A

Interventions

  • Diagnostic: [18F]FluorThanatrace
    Summary: A fluorine-18 radiolabeled rucaparib analogue that targets PARP-1 protein for PET imaging. PARP-1 is overexpressed in many cancers and plays a key role in DNA repair; this radiotracer enables visualization of PARP-1-expressing tumor cells. Source: NCI Thesaurus and Web Search.

Key Inclusion

  • Age ≥18 years
  • Metastatic or unresectable grade 1, 2, or 3 pancreatic neuroendocrine tumor
  • At least one lesion ≥1.5 cm on clinical imaging
  • May be receiving any treatment or no current treatment
  • Willing to consent to tumor tissue use
  • Able to provide informed consent

Key Exclusion

  • Received liver directed therapy treating all disease without progression
  • Inability to tolerate imaging procedures
  • Pregnant or breastfeeding females
  • Medical condition compromising safety or study participation

NCT07059975

UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML: A Pilot Trial Genomic-based

Organization/Sponsor: Baylor College of Medicine


Example patient: A 7-year-old with newly diagnosed AML harboring RUNX1::RUNX1T1 translocation, ejection fraction 55%, who completed DA10+GO induction and has normal renal and hepatic function.

Phase N/A

Interventions

  • Standard of Care: SOC
    Summary: Standard of care refers to conventional therapies including chemotherapy and radiation, working through cell cycle disruption and DNA damage (Summary of Web Search, NCI Thesaurus).
  • Drug: Intrathecal triple
    Summary: Combination of methotrexate, cytarabine, and hydrocortisone delivered intrathecally to prevent CNS relapse in high-risk leukemia through direct CNS delivery (Summary of Web Search, NCI Thesaurus).
  • Biological: Asparaginase Erwinia Chrysanthemi (recombinant)
    Summary: Recombinant bacterial enzyme that depletes asparagine by converting L-asparagine to L-aspartic acid, blocking protein synthesis in leukemia cells lacking asparagine synthase, used for hypersensitivity to E. coli asparaginase (FDA label, NCI Thesaurus).
  • Drug: Etoposide
    Summary: Semisynthetic podophyllotoxin derivative that inhibits topoisomerase II, preventing DNA replication and transcription, causing apoptotic cell death primarily in G2 and S phases (FDA label, NCI Thesaurus).
  • Drug: Venetoclax
    Summary: Selective BCL-2 inhibitor that mimics BH3-only proteins, binding to BCL-2 hydrophobic groove to restore apoptosis in tumor cells without causing bcl-XL-mediated thrombocytopenia (FDA label, NCI Thesaurus).
  • Drug: Cytarabine (Ara-C)
    Summary: Nucleoside metabolic inhibitor that incorporates into DNA and inhibits nucleic acid synthesis, disrupting cancer cell replication in acute leukemias via IV, subcutaneous, or intrathecal routes (FDA label, Summary of Web Search).
  • Drug: Fludarabine
    Summary: Fluorinated nucleotide analog phosphorylated to 2-fluoro-ara-ATP, inhibiting DNA polymerase alpha, ribonucleotide reductase, and DNA primase to interrupt DNA synthesis in leukemia cells (FDA label, NCI Thesaurus).
  • Drug: Idarubicin Hydrochloride
    Summary: Anthracycline antibiotic that intercalates DNA and inhibits topoisomerase II, with high lipophilicity enabling efficient cell membrane penetration for treating AML (FDA label, NCI Thesaurus).

Key Inclusion

  • Age 1 month to 30 years
  • AML or myeloid sarcoma per 2022 WHO classification
  • ≥20% bone marrow blasts or specific genetic abnormalities
  • Prior DA10+GO induction therapy
  • Karnofsky/Lansky performance status >40
  • Creatinine clearance ≥60 ml/min/1.73m2
  • Ejection fraction ≥50% or shortening fraction ≥24%
  • Direct bilirubin <2 mg/dL and ALT <5x ULN

Key Exclusion

  • Constitutional conditions: Fanconi anemia, Schwachman Diamond Syndrome, telomere disorders, trisomy 21
  • Therapy-related AML
  • Acute promyelocytic leukemia
  • AML with FLT3-ITD
  • Mixed phenotype acute leukemia
  • Philadelphia chromosome positive AML
  • Pregnancy or breastfeeding
  • Concurrent malignancy

NCT06923397

Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial

Organization/Sponsor: Dana-Farber Cancer Institute


Example patient: A 52-year-old English-speaking patient with newly diagnosed diffuse large B-cell lymphoma starting R-CHOP chemotherapy who is currently sedentary with less than 60 minutes of weekly exercise and has physician clearance for physical activity.

Phase N/A

Interventions

  • Behavioral: Interrupted Sedentary Time Intervention
    Summary: Behavioral intervention using wearable fitness trackers and exercise programs to reduce prolonged inactivity periods, aiming to improve cardiometabolic health and reduce chemotherapy-related toxicity in lymphoma patients (Source: Web Search).

Key Inclusion

  • Diagnosed with lymphoma
  • Receiving first line R-CHOP or POLA-R-CHP chemotherapy
  • Aged 18 years or older
  • Engaging in less than 60 minutes of structured moderate or vigorous intensity exercise
  • Physician clearance to participate in exercise
  • Willing to travel to Dana-Farber Cancer Institute
  • Access to phone that can receive text messages

Key Exclusion

  • Unstable comorbidities preventing moderate-to-vigorous intensity exercise
  • Participate in more than 60 minutes of structured moderate-to-vigorous exercise per week
  • Receiving treatment for other active malignancies except basal cell carcinoma
  • Unable to comply with safety monitoring requirements
  • Unable to travel to DFCI Longwood campus

NCT07015242

The CAROLYN Trial: Lisocabtagene Maraleucelas First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients

Organization/Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company


Example patient: A 68-year-old patient with newly diagnosed primary CNS lymphoma who achieved partial response to high-dose methotrexate, has ECOG status 1, and is transplant-ineligible due to age and comorbidities.

Phase N/A

Interventions

  • Biological: Rituximab
    Summary: Chimeric monoclonal antibody targeting CD20 on B cells, inducing cell death via antibody-dependent cytotoxicity for treating CD20-positive B-cell malignancies including non-Hodgkin's lymphoma and chronic lymphocytic leukemia (FDA label, NCI Thesaurus).
  • Drug: Methotrexate
    Summary: Dihydrofolate reductase inhibitor that blocks folate metabolism, inhibiting DNA and RNA synthesis in cancer cells, used for acute lymphoblastic leukemia and non-Hodgkin lymphoma (FDA label, NCI Thesaurus).
  • Drug: Procarbazine
    Summary: Alkylating agent that interferes with cancer cell division, used in combination chemotherapy regimens for Hodgkin's lymphoma and non-Hodgkin's lymphoma (Web Search).
  • Drug: Temozolomide
    Summary: Alkylating agent that methylates DNA at O6 and N7 positions of guanine, disrupting replication, indicated for glioblastoma and anaplastic astrocytoma with good CNS penetration (FDA label, NCI Thesaurus).
  • Biological: Liso-cel
    Summary: CD19-directed CAR T-cell therapy targeting CD19-positive B cells, used for relapsed or refractory B-cell lymphomas including diffuse large B-cell lymphoma (Web Search).
  • Drug: Fludarabine
    Summary: Fluorinated nucleotide analog that inhibits DNA polymerase, ribonucleotide reductase, and DNA primase, indicated for B-cell chronic lymphocytic leukemia refractory to alkylating agents (FDA label, NCI Thesaurus).
  • Drug: Cyclophosphamide
    Summary: Alkylating agent converted to active metabolites that bind DNA and inhibit replication, used for lymphomas, leukemias, and solid tumors with immunosuppressive activity (FDA label, NCI Thesaurus).
  • Drug: Calcium folinate
    Summary: Folate coenzyme used as rescue therapy to counteract toxic effects of folic acid antagonists like methotrexate, protecting normal cells during chemotherapy (Web Search).

Key Inclusion

  • Age 18 years or older
  • Histologically confirmed primary CNS lymphoma
  • Transplant-ineligible (age ≥65 or HCT-CI score ≥3)
  • Suitable for high-dose methotrexate-based treatment
  • Disease sensitive to prior HD-MTX (complete or partial response)
  • ECOG performance status 0, 1, or 2
  • Negative pregnancy test for individuals of childbearing potential

Key Exclusion

  • Secondary CNS lymphoma due to systemic disease
  • Primary intraocular lymphoma or isolated CSF disease
  • History of another primary malignancy not in remission for ≥2 years
  • Prior CAR T-cell or gene therapy product
  • Active or history of HIV
  • Active hepatitis B or C
  • Active autoimmune disease requiring immunosuppressive therapy

NCT06510309

A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma

Organization/Sponsor: Beth Israel Deaconess Medical Center


Example patient: A 62-year-old woman with treatment-naive marginal zone lymphoma presenting with a 2.5 cm cervical lymph node, ECOG status 0, normal organ function, and no prior systemic therapy.

Phase II

Interventions

  • Drug: Rituximab
    Summary: Chimeric monoclonal antibody targeting CD20 on B cells, inducing cell death via antibody-dependent cellular cytotoxicity, indicated for CD20-positive B-cell malignancies including non-Hodgkin's lymphoma and chronic lymphocytic leukemia (FDA label, NCI Thesaurus).
  • Drug: Venetoclax
    Summary: Selective BCL-2 inhibitor that binds to BCL-2 protein to restore apoptosis in cancer cells, indicated for chronic lymphocytic leukemia, small lymphocytic lymphoma, and acute myeloid leukemia (FDA label, NCI Thesaurus).

Key Inclusion

  • Histologically confirmed Marginal Zone Lymphoma
  • Measurable disease with at least one lymph node ≥1.5 cm or spleen >13 cm
  • Age ≥18 years
  • ECOG performance status ≤1
  • Absolute neutrophil count ≥1,000 cells/mcL
  • Platelets ≥50,000 cells/mm3
  • Creatinine clearance >60 mL/min
  • Gastric MALT lymphoma must be h. pylori negative or failed eradication

Key Exclusion

  • Prior systemic therapy including rituximab
  • Prior treatment with ibrutinib or other BTK inhibitor
  • H. pylori-associated gastric MALT or stage I/II MZL fit for curative radiation
  • Uncontrolled hepatitis B, C, or HIV infection with detectable viral load
  • Pregnant or unwilling to use contraception for 12 months after rituximab
  • Received moderate or strong CYP3A inhibitors within 7 days
  • Received moderate or strong CYP3A inducers within 7 days
  • Uncontrolled intercurrent illness or active infection

NCT06517017

Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma: A Phase 2 Multicenter Study

Organization/Sponsor: University of Utah


Example patient: A 78-year-old frail male with newly diagnosed multiple myeloma, IMWG frailty score of 4, who received one cycle of prior therapy and has recovered to Grade 1 toxicity.

Phase 2

Interventions

  • Drug: Isatuximab
    Summary: Isatuximab is a monoclonal antibody targeting CD38 that induces apoptosis in CD38-positive cells, FDA-approved for relapsed/refractory multiple myeloma (Source: Web Search).

Key Inclusion

  • Aged ≥18 years
  • Histologically confirmed myeloma and/or Plasma Cell Leukemia newly diagnosed
  • Completed ≤1 prior cycle of myeloma treatment
  • IMWG defined frailty score ≥3
  • Willing to follow contraception requirements and Lenalidomide REMS program
  • Recovery to baseline or ≤Grade 1 CTCAE v5 from prior treatment toxicities

Key Exclusion

  • Receiving other investigational agents
  • Known prior severe hypersensitivity (Grade ≥3) to investigational product or components
  • History of intolerance to steroids, mannitol, or other study intervention components
  • Condition compromising ability to give informed consent or participate safely
  • Currently taking prohibited medications

NCT07052305

A Phase 1b Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Yescarta® (Axicabtagene Ciloleucel) or Post-Breyanzi® (Lisocabtagene Maraleucel) in Subjects With Relapsed/Refractory Large B-cell Lymphoma

Organization/Sponsor: Washington University School of Medicine


Example patient: A 52-year-old patient with relapsed diffuse large B-cell lymphoma after two prior therapies, ECOG performance status 1, with measurable FDG-avid disease and adequate organ function, eligible for CD19 CAR T-cell therapy.

Phase 1

Interventions

  • Biological: CAR T-cell therapy
    Summary: CAR T-cell therapy uses engineered T-cells to target cancer cells by reprogramming them to attack specific cancer antigens. FDA-approved for certain blood cancers including leukemia and lymphoma. Source: Summary of Web Search.
  • Biological: NT-I7
    Summary: NT-I7 is a long-acting IL-7 therapy that enhances T-cell function by targeting IL-7 receptors to boost immune responses. Designed to sustain CAR-T efficacy in lymphoma. Source: Summary of Web Search.

Key Inclusion

  • Histologically confirmed relapsed or refractory large B-cell lymphoma including DLBCL NOS, high grade B-cell lymphoma, DLBCL from indolent lymphoma, grade 3B follicular lymphoma, and primary mediastinal large B-cell lymphoma
  • Measurable disease by IWG response criteria for lymphoma
  • Eligible for FDA-approved SOC CD19 CAR T-cell therapy (Yescarta or Breyanzi)
  • At least 18 years of age
  • ECOG performance status ≤ 2
  • Adequate bone marrow function: ANC ≥ 1.0 K/cumm, platelets ≥ 50 K/cumm, hemoglobin ≥ 8.0 g/dL
  • Adequate organ function: bilirubin ≤ 1.5 x IULN, AST/ALT ≤ 2.5 x IULN, creatinine clearance ≥ 30 mL/min
  • QTcF < 500 ms on ECG

Key Exclusion

  • Previous allogeneic solid organ or bone marrow transplant
  • Documented active CNS involvement by lymphoma
  • Chemotherapy, biologic, or hormonal cancer therapy within 14 days prior to first NT-I7 injection
  • Investigational agents within 14 days prior to first NT-I7 injection
  • History of autoimmune disease within past 2 years
  • Cardiac events within 6 months: myocardial infarction, unstable angina, coronary procedures, or congestive heart failure NYHA Class ≥ 2
  • Pregnant or breastfeeding
  • HIV with detectable viral load or not on effective antiretroviral therapy for 6 months