Leukemia and Lymphoma Clinical Trials Intelligence

Monthly Update Report for Trials Started in August 2026

Powered by Sophic Starlight

Disclaimer and Important Notice:

Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is provided for educational and consulting purposes only. This report is not a substitute for professional medical advice, diagnosis, or treatment. Sophic shall not be held responsible for any interpretation, application, or use of this report beyond these purposes.

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. Reports are provided entirely free of charge, and patients should never be billed or charged for access to this information. Users agree to reference Sophic in any publication, presentation, or publicity that incorporates or relies upon information from Sophic Starlight Cancer Clinical Trials Intelligence Reports.

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

Overview

Number of Trials: 27

The 27 trials primarily focus on hematologic malignancies (leukemia, lymphoma, myeloma) and myelodysplastic syndromes, evaluating novel targeted agents, CAR T-cell therapies, BTK degraders, checkpoint inhibitors, and supportive/behavioral interventions. Several trials also address survivorship, quality of life, and substance use disorder treatment in cancer-adjacent or unrelated populations.

Common Criteria Across Trials

Common Inclusion

Age ≥18 years (most adult trials)
ECOG performance status ≤2
Adequate organ and bone marrow function
Histologically/cytologically confirmed diagnosis of target malignancy
Measurable disease per standard criteria (e.g., iwCLL, Lugano, IWG)
Negative pregnancy test and use of contraception for participants of childbearing potential
Prior therapy requirements (relapsed/refractory after specified prior lines)

Common Exclusion

Active or uncontrolled infections (including HIV, HBV, HCV unless controlled)
Significant cardiac disease (e.g., LVEF <40%, uncontrolled arrhythmia, recent MI)
CNS involvement by malignancy
Active autoimmune disease requiring systemic treatment
Pregnancy or breastfeeding
Recent investigational therapy or anti-cancer treatment within specified washout period
Prior allogeneic transplant complications or active GVHD

Outcomes Summary

Primary Outcomes

Overall response rate / complete response rate (9 trials)
Safety and tolerability / adverse events (10 trials)
Progression-free survival (5 trials)
Maximum tolerated dose / recommended phase 2 dose (6 trials)
Feasibility/acceptability of intervention (4 trials)

Secondary Outcomes

Overall survival (6 trials)
Duration of response (4 trials)
Quality of life measures (5 trials)
Pharmacokinetics (4 trials)
Minimal residual disease status (3 trials)

2: Extracted Trials with New Information

Trials with Special Criteria

Genomic / Biomarker Trials

NCT07021989 — Uses ctDNA (Foresight CLARITY) MRD detection to guide consolidation therapy
NCT07511062 — Requires TP53 mutation or deletion by molecular/FISH/IHC testing
NCT07617363 — Requires TP53 alteration (mutation, deletion, or IHC overexpression) for dose expansion
NCT07634536 — Eligibility based on cytogenetics (complex karyotype, TP53 mutation, MECOM rearrangement)
NCT07751991 — Requires NPM1 mutation or KMT2A/NUP98 rearrangement
NCT06789159 — Requires EBV-positive tumor status
NCT07572929 — Uses NGS/flow/PCR-based measurable residual disease detection

Unique or Unusual Criteria

NCT07022678 — Non-drug oral hygiene intervention using xylitol wipes to prevent infection during chemotherapy
NCT07573111 — Investigational Listeria-based biologic product tested post-specialized HSCT
NCT07631598 — Focus on opioid use disorder treatment, unrelated to cancer but included in dataset
NCT05974202 — Neurostimulation trial for substance use disorder, unrelated to oncology
NCT07451054 — Combines CAR T-cell therapy with base-edited stem cells to protect healthy hematopoiesis

Trials with Emerging Treatments

NCT07516093 — NX-5948 Versus Pirtobrutinib in R/R CLL/SLL
Items: NX-5948 (bexobrutideg)
Note: Novel oral BTK degrader without FDA approval, tested head-to-head vs approved noncovalent BTKi
NCT07617363 — ATRN-119 With Decitabine in TP53-Mutated AML/HR-MDS
Items: ATRN-119
Note: Selective ATR inhibitor without FDA approval, novel DNA repair pathway targeting
NCT07751991 — CHM-029 in R/R AML With NPM1/KMT2A/NUP98 Alterations
Items: CHM-029
Note: Next-generation menin inhibitor designed to overcome resistance mutations, first-in-human
NCT06789159 — VK-2019 in R/R EBV+ DLBCL
Items: VK-2019
Note: Targets EBNA-1 protein, novel antiviral/anti-tumor mechanism for EBV-associated lymphoma
NCT07451054 — Anti-CD45 CAR T Cells With CD45 Base Edited HSPCs
Items: CD45BE-HSPC, CART-45 cells
Note: Combines base-edited stem cells with CAR T therapy to protect normal hematopoiesis, highly novel platform
NCT07424833 — APG-3288 in R/R Hematological Malignancies
Items: APG-3288
Note: Novel BTK-targeted protein degrader using PROTAC technology, IND-stage
NCT07573111 — QUAIL-100 in Pediatric High-Risk Leukemia Post HSCT
Items: QUAIL-100
Note: Investigational Listeria-based biologic, first-in-human study
NCT06863402 — Nemtabrutinib and Pembrolizumab in Richter Transformation
Items: Nemtabrutinib
Note: Reversible BTK inhibitor active against C481S resistance mutation, not yet FDA approved
NCT07021989 — Pembrolizumab and GVD With ctDNA-guided Consolidation in Hodgkin Lymphoma
Items: Foresight CLARITY™ LDT
Note: Ultra-sensitive ctDNA MRD platform guiding treatment decisions, novel diagnostic-therapeutic integration

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 45-year-old man with relapsed classic Hodgkin lymphoma after one prior doxorubicin-based regimen, ECOG 1, normal organ function, and no prior transplant or checkpoint inhibitor exposure, would qualify for this trial.

Phase 2

Interventions

Diagnostic: FDG PET/CT
Summary: Functional/anatomical imaging used to detect FDG-avid lymphoma sites for staging and response assessment. Source: Web Search Summary.
Biologic (Growth factor): Pegfilgrastim
Summary: G-CSF analog stimulating neutrophil production to prevent chemotherapy-induced neutropenia. Source: FDA label, NCI Thesaurus.
Diagnostic (MRD assay): Foresight CLARITY™ LDT
Summary: Ultra-sensitive ctDNA-based PhasED-Seq assay for minimal residual disease detection guiding consolidation decisions. Source: Web Search Summary.
Drug (Chemotherapy): Liposomal Doxorubicin
Summary: Anthracycline topoisomerase II inhibitor encapsulated in liposomes, causing DNA damage in lymphoma cells with reduced cardiotoxicity. Source: FDA label, NCI Thesaurus.
Drug (Chemotherapy): Vinorelbine
Summary: Vinca alkaloid inhibiting microtubule assembly, blocking mitosis in lymphoma cells; part of GVD regimen. Source: FDA label, NCI Thesaurus.
Drug (Chemotherapy): Gemcitabine
Summary: Nucleoside analog inhibiting DNA synthesis and ribonucleotide reductase, used in combination chemotherapy for relapsed lymphoma. Source: FDA label, NCI Thesaurus.
Radiotherapy: Involved Site Radiotherapy (ISRT)
Summary: Targeted radiation to residual lymphoma sites per ILROG guidelines, used as consolidation. Source: Web Search Summary.
Biologic (Immune checkpoint inhibitor): Pembrolizumab
Summary: Humanized anti-PD-1 monoclonal antibody enhancing T-cell mediated anti-tumor immunity, combined with GVD chemotherapy for relapsed/refractory Hodgkin lymphoma. Source: FDA label, NCI Thesaurus.

Key Inclusion

Age ≥18 years
Classic Hodgkin lymphoma, relapsed/refractory after ≤1 prior systemic therapy including doxorubicin
FDG-avid measurable disease on PET/CT
ECOG 0-2
Adequate organ function (ANC, platelets, bilirubin, AST/ALT, CrCl)
Controlled HBV/HCV/HIV infection permitted
Negative pregnancy test for females of reproductive potential
Willing/able to give informed consent

Key Exclusion

Prior PD-1 inhibitor therapy with progression within 6 months
Prior autologous or allogeneic stem cell transplant
Systemic autoimmune disease requiring immunosuppression
LVEF <50%
Cumulative doxorubicin exposure exceeding limit
Known hypersensitivity to trial drugs
Uncontrolled comorbidity or infection
Pregnant or breastfeeding individuals

NCT07516093

A Phase 3, Randomized, Open-label, Multicenter Study of NX-5948 Versus Pirtobrutinib in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Organization/Sponsor: Nurix Therapeutics, Inc.

Example patient: A 68-year-old man with relapsed CLL after ibrutinib therapy, ECOG 1, normal organ function, and no recent cardiac or thromboembolic events, eligible for randomization to NX-5948 or pirtobrutinib.

Phase 3

Interventions

Drug: Pirtobrutinib
Summary: Oral non-covalent, reversible BTK inhibitor blocking BCR signaling to inhibit malignant B-cell growth; FDA-approved for R/R CLL/SLL and MCL after prior BTK inhibitor therapy. Source: FDA label, NCI Thesaurus.
Drug: NX-5948
Summary: Oral BTK degrader (CRBN-based chimeric molecule) that induces ubiquitination and proteasomal degradation of BTK, blocking BCR signaling; crosses blood-brain barrier, investigational in R/R CLL/SLL. Source: NCI Thesaurus, Web Search.

Key Inclusion

ECOG performance status 0-2
Adequate organ and bone marrow function
Confirmed CLL/SLL diagnosis per iwCLL 2018 criteria
At least 1 prior line of therapy including a covalent BTK inhibitor
Documented disease progression during/after cBTKi therapy
Measurable disease by CT for SLL patients

Key Exclusion

Known/suspected prolymphocytic leukemia or Richter's transformation
Investigational or anticancer therapy within 5 half-lives or 14 days
Ongoing systemic corticosteroids ≥10 mg/day prednisone equivalent
Prior treatment with a BTK degrader or noncovalent BTKi
Recent myocardial infarction or significant cardiac condition within 6 months
Recent thromboembolic event, stroke, or intracranial hemorrhage within 6 months

NCT07014293

Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors

Organization/Sponsor: Massachusetts General Hospital

Example patient: A 45-year-old English-speaking woman, 10 months post-Hodgkin lymphoma diagnosis and 4 months after completing chemotherapy, is mentally stable and comfortable using telehealth for the study.

Phase N/A

Interventions

Behavioral: SMART3RP-Lymphoma
Summary: A mind-body resiliency program using stress management and relaxation techniques to help lymphoma survivors adapt to chronic stress and improve quality of life post-treatment. Source: Summary of Web Search.
Behavioral: Enhanced Usual Care
Summary: Standard supportive care serving as a control condition, without targeted resiliency intervention, for comparison against SMART3RP-Lymphoma. Source: Summary of Web Search.

Key Inclusion

English speaking adult (18+)
At least 6 months post-lymphoma diagnosis
Within 2 years of completing curative treatment
Completed treatment: surgery, chemo/immunotherapy/radiation

Key Exclusion

Active psychiatric or cognitive comorbidity
Unwilling/unable to use telehealth platform

NCT07725406

A Phase Ib, Dose-Escalation Study of Augmented Lymphodepletion and CAR T-cell Priming With Low-dose Total Body Irradiation in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphomas and Multiple Myeloma Receiving Treatment With Commercial CD19 or BCMA-directed CAR T-cell Therapies

Organization/Sponsor: Weill Medical College of Cornell University

Example patient: A 55-year-old man with DLBCL relapsed after two prior chemoimmunotherapy regimens, ECOG 1, normal organ function, no CNS disease, and no prior CAR-T or TBI exposure.

Phase 1

Interventions

Radiation: Low-Dose Total Body Irradiation
Summary: Low-dose radiation used to augment lymphodepletion and prime CAR T-cell expansion by suppressing host immunity and clearing target antigen-positive cells. Source: Summary of Web Search.
Biologic (CAR T-cell therapy): Ciltacabtagene Autoleucel
Summary: BCMA-directed CAR T-cell therapy that reprograms autologous T-cells to target BCMA on myeloma cells; FDA-approved for relapsed/refractory multiple myeloma. Source: Summary of Web Search.
Biologic (CAR T-cell therapy): Axicabtagene Ciloleucel
Summary: CD19-directed autologous CAR T-cell therapy used for relapsed/refractory large B-cell lymphoma.
Biologic (CAR T-cell therapy): Lisocabtagene Maraleucel
Summary: CD19-directed autologous CAR T-cell therapy for relapsed/refractory large B-cell lymphoma.
Chemotherapy (lymphodepletion): Fludarabine
Summary: Lymphodepleting agent inhibiting DNA synthesis in lymphocytes to enhance CAR-T engraftment. Source: Summary of Web Search.
Chemotherapy (lymphodepletion): Bendamustine
Summary: Alkylating agent used for lymphodepletion prior to CAR-T therapy, inhibiting DNA synthesis in dividing lymphocytes. Source: Summary of Web Search.
Chemotherapy (lymphodepletion): Cyclophosphamide
Summary: Alkylating agent that depletes host lymphocytes to enhance adoptive cell therapy efficacy. Source: Summary of Web Search.

Key Inclusion

Relapsed/refractory DLBCL after ≥2 lines of therapy or early relapse
Relapsed/refractory multiple myeloma refractory to lenalidomide
Age ≥18 years
ECOG performance status ≤2
Measurable disease on PET/CT or CT (DLBCL)
Adequate organ function (ANC, platelets, renal, hepatic, cardiac)
Left ventricular ejection fraction >40%

Key Exclusion

Prior total body irradiation
Prior CAR T-cell therapy
History of myelodysplastic syndrome or CCUS
CNS involvement by lymphoma or myeloma
Active HIV, hepatitis B, or hepatitis C
Uncontrolled active infection
Significant cardiovascular impairment
Pregnancy

NCT07511062

Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated/Deleted AML Patients Genomic-based

Organization/Sponsor: Northside Hospital, Inc.

Example patient: A 68-year-old man with newly diagnosed AML harboring a TP53 mutation, KPS 80, normal renal/hepatic function, and no active infection or GVHD, eligible for first-line treatment.

Phase N/A

Interventions

Monoclonal antibody (BLA): Axatilimab
Summary: Humanized IgG4 monoclonal antibody blocking CSF-1R signaling, reducing pro-inflammatory/pro-fibrotic macrophages and TAM-mediated immunosuppression; FDA-approved for cGVHD, being explored here for TP53-mutated AML. Source: FDA label/NCI Thesaurus.
Small molecule (NDA): Venetoclax
Summary: Oral selective BCL-2 inhibitor that restores apoptosis in leukemic cells by mimicking BH3-only proteins; approved for CLL/SLL and AML combination therapy. Source: FDA label/NCI Thesaurus.
Small molecule (ANDA): Decitabine
Summary: Cytidine analogue DNA methyltransferase inhibitor causing DNA hypomethylation and S-phase arrest, used in MDS/AML to reactivate tumor suppressor genes. Source: FDA label/NCI Thesaurus.

Key Inclusion

MDS/AML or AML with TP53 mutation/deletion ≥10% blasts
TP53 mutation, deletion by FISH, or positive IHC staining
Untreated or first salvage (primary refractory or first relapse)

Key Exclusion

KPS <60
Active uncontrolled infection
HIV or active HBV/HBC infection
Active second malignancy
CrCl <40 mL/min
AST/ALT/direct bilirubin >3x ULN
Cardiac ejection fraction <40% or uncontrolled arrhythmias
History of pancreatitis, myositis, CNS leukemia, recent HSCT, or active GVHD

NCT07617363

A Phase I Study of ATRN-119, an ATR Inhibitor, in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS Genomic-based

Organization/Sponsor: Washington University School of Medicine

Example patient: A 65-year-old man with relapsed AML harboring a TP53 mutation, ECOG 1, normal organ function, and no active infections or GVHD, seeking new treatment options.

Phase 1

Interventions

Drug: Decitabine
Summary: Hypomethylating nucleoside analogue that incorporates into DNA, inhibits DNA methyltransferase, causing hypomethylation and S-phase arrest; FDA-approved for MDS. Source: FDA label, NCI Thesaurus.
Drug: ATRN-119
Summary: Investigational selective ATR inhibitor that disrupts DNA damage repair pathways, sensitizing malignant cells to replication stress; being studied for AML/MDS. Source: Summary of Web Search.

Key Inclusion

AML or higher-risk MDS by WHO/ICC criteria
Untreated AML with ELN adverse-risk features, ineligible for intensive chemo
Relapsed/refractory AML or HR-MDS meeting defined failure criteria
TP53 alteration required for dose expansion cohort
Age ≥18 years, ECOG ≤2
Adequate hepatic, renal, and organ function
Willing to use contraception during and after treatment

Key Exclusion

Prior therapy for AML/MDS in expansion cohort (with exceptions)
Active CNS leukemia involvement
Active GVHD requiring systemic immunosuppression
Concurrent malignancy affecting safety/efficacy assessment
Use of strong CYP3A4 inhibitors/inducers
Uncontrolled infection or cardiac disease
Pregnant or breastfeeding
Uncontrolled HIV, HBV, or HCV infection

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 6-year-old boy newly diagnosed with AML per WHO 2016 criteria, planned for two cycles of IV cytarabine chemotherapy, with erupted teeth, no allergies to xylitol or grape flavoring, and no prior head/neck radiation.

Phase N/A

Interventions

Oral care product: Xylitol-containing Oral Wipe
Summary: Xylitol oral wipes reduce cariogenic bacteria, hydrate oral mucosa, and may prevent mucosal barrier injury-related bloodstream infections in pediatric AML patients undergoing chemotherapy. Source: NCI Thesaurus, web search.
Control: Placebo Administration
Summary: Inactive substance used as a comparator to assess efficacy of xylitol wipes in preventing bloodstream infections. Source: NCI Thesaurus.
Data collection: Electronic Health Record Review
Summary: Review of patient EHR data to monitor outcomes, infections, and treatment response during the trial. Source: NCI Thesaurus.
Chemotherapy: Cytarabine
Summary: Antimetabolite chemotherapy that inhibits DNA synthesis and replication in leukemic cells, used as part of standard AML treatment regimens causing neutropenia risk. Source: FDA label, NCI Thesaurus.
Procedure: Biospecimen Collection
Summary: Collection of biological samples for correlative research into infection risk and treatment outcomes. Source: NCI Thesaurus.
Standard of care: Best Practice
Summary: Represents standard supportive care practices used as comparison or baseline during trial treatment. Source: NCI Thesaurus.

Key Inclusion

Age 1 to 25 years
Diagnosis of AML (WHO 2016 criteria)
Newly diagnosed or relapsed AML
Planned ≥2 cycles of IV cytarabine-based myelosuppressive chemotherapy
Expected severe neutropenia ≥7 days per cycle
At least one visible or erupted tooth
Willing to avoid other xylitol products during study
Informed consent obtained

Key Exclusion

Down syndrome-associated AML
Prior head/neck/oral radiation within 6 months
Known xylitol allergy
Known grape or grape flavoring allergy
Active oral-organism bloodstream infection treatment
Unable to comply with oral wipe use

NCT07178912

Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL) Genomic-based

Organization/Sponsor: M.D. Anderson Cancer Center

Example patient: A 45-year-old man newly diagnosed with Philadelphia chromosome-positive ALL, ECOG performance status 1, normal liver and cardiac function, and no history of CNS disease or uncontrolled infections.

Phase 2

Interventions

Tyrosine kinase inhibitor: Olverembatinib
Summary: Third-generation BCR-ABL/T315I and c-KIT inhibitor used to treat CML and Ph-positive ALL by blocking oncogenic kinase signaling. Source: Summary of Web Search.
Bispecific T-cell engager (BiTE) antibody: Blinatumomab
Summary: CD19xCD3 bispecific antibody engaging T cells to kill CD19-positive B-cell precursor ALL cells; FDA-approved for various ALL settings, with risks of cytokine release syndrome and neurotoxicity. Sources: FDA label, NCI Thesaurus, Summary of Web Search.

Key Inclusion

Age ≥18 years
Newly diagnosed or relapsed/refractory Ph-positive and/or BCR::ABL1-positive ALL
Lymphoid accelerated or blast phase CML
ECOG performance status ≤2
Adequate liver function (bilirubin <2x ULN, ALT/AST <3x ULN)
Adequate pancreatic function (lipase/amylase <1.5x ULN)
Negative pregnancy test for females of childbearing potential
Adequate cardiac function by history/exam

Key Exclusion

Active uncontrolled serious infection
Active secondary malignancy limiting survival <1 year
Grade III-V cardiac failure or uncontrolled cardiovascular disease
Recent MI, stroke, or revascularization within 3 months
Prolonged QTc >470 msec uncorrected
History of significant CNS pathology (seizures, stroke, dementia)
Pregnant or lactating women
History of significant bleeding disorder

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 girl with B-cell ALL currently on maintenance chemotherapy, fluent in English, with a supportive adult caregiver, able to walk briskly for five minutes, and a negative SCOFF eating disorder screen.

Phase N/A

Interventions

Educational/Behavioral: WashU Extended Learning Canvas
Summary: An educational platform used to deliver program content in this behavioral trial; unrelated cited mechanisms (CAR-T, gene editing) appear inaccurate for this context. Source: Summary of Web Search.
Device/Behavioral: FitBit Ace
Summary: Wearable activity tracker monitoring steps, heart rate, and sleep to encourage exercise and track physical activity in pediatric cancer survivors. Source: NCI Thesaurus, Summary of Web Search.
Educational: NIH Educational Resources
Summary: Educational materials used to support patient/caregiver understanding, though specific mechanistic details are not well defined in source data. Source: Summary of Web Search.
Behavioral: Modified Guided Self-Help Family Intervention
Summary: A family-based counseling and self-help intervention targeting weight management and coping strategies for pediatric leukemia survivors and caregivers. Source: Summary of Web Search.

Key Inclusion

Diagnosis of ALL (T or B cell)
Receiving or within 6 months of completing maintenance chemotherapy
Age 6–18 years
English speaking/understanding
Has a participating caregiver
Able to perform light exercise (e.g., 5-minute brisk walk)
Negative SCOFF eating disorder screen (if age 10+)
Able to provide consent/assent

Key Exclusion

Severe developmental delay or intellectual disability
Significant mental illness (active suicidal ideation, psychosis, mania, severe substance use)
SCOFF score ≥2 (disordered eating risk)
Caregiver not participating
Caregiver under 18 years
Non-English speaking caregiver or patient
Caregiver unable to exercise

NCT07551583

A Phase II Single Arm Study to Evaluate Safety and Preliminary Efficacy of Nivolumab Plus AVD in Pediatric, Adolescent, And Young Adult Patients With Newly Diagnosed Early-stage Non-bulky Classical Hodgkin Lymphoma

Organization/Sponsor: M.D. Anderson Cancer Center

Example patient: A 15-year-old girl newly diagnosed with early-stage, non-bulky classical Hodgkin lymphoma, with normal cardiac and organ function, no prior therapy, and no autoimmune disease or infections, eligible for Nivolumab plus AVD treatment.

Phase II

Interventions

Chemotherapy - Alkylating Agent: Dacarbazine
Summary: Alkylating agent that cross-links DNA, causing cell cycle arrest and apoptosis; used in combination regimens for Hodgkin's disease. Source: FDA label, NCI Thesaurus.
Chemotherapy - Vinca Alkaloid: Vinblastine
Summary: Binds tubulin to inhibit microtubule formation, arresting cells in mitosis; indicated for Hodgkin's disease and lymphomas in combination regimens. Source: FDA label, NCI Thesaurus.
Chemotherapy - Anthracycline: Doxorubicin Hydrochloride
Summary: Anthracycline that intercalates DNA and inhibits topoisomerase II, blocking replication; used for leukemias and lymphomas with known cardiotoxicity risk requiring cardiac monitoring. Source: FDA label, NCI Thesaurus.
Immunotherapy - PD-1 Inhibitor (Monoclonal Antibody): Nivolumab
Summary: Fully human IgG4 monoclonal antibody blocking PD-1 receptor, restoring T-cell mediated antitumor immunity; approved for multiple advanced cancers, combined here with AVD chemotherapy for Hodgkin lymphoma. Source: FDA label, NCI Thesaurus.

Key Inclusion

Age 2 to 21 years
Newly diagnosed early-stage (I/II) non-bulky (<10cm) classical Hodgkin lymphoma
Baseline ejection fraction > 40%
Adequate hepatic and renal function
ECOG performance status ≤2 (Karnofsky ≥60%)
No prior systemic therapy for lymphoma (except brief steroids)
Cardiac risk class 2B or better (NYHA)
Agreement to contraception per protocol

Key Exclusion

Prior systemic lymphoma therapy (except limited steroids)
Weight less than 10kg
Severe allergy to Nivo-AVD components
Active/prior autoimmune disease within 2 years
Current immunosuppressive medication use (with exceptions)
Active HIV, HBV, or HCV infection unless controlled
Concurrent active malignancy under treatment
Pregnant or breastfeeding women

NCT07634536

Automated Total Marrow and Lymphoid Irradiation for Allogeneic Hematopoietic Cell Transplant Genomic-based

Organization/Sponsor: Stanford University

Example patient: A 45-year-old man with TP53-mutated AML and 15% marrow blasts after two prior therapy lines, Karnofsky 80%, normal organ function, receiving his first allogeneic PBSC transplant from an 8/8 matched unrelated donor.

Phase N/A

Interventions

Immunosuppressant: Tacrolimus
Summary: Calcineurin inhibitor that blocks T-cell activation and IL-2 production, used for GVHD prophylaxis after transplant. Source: FDA label.
Immunosuppressant: Mycophenolate mofetil (MMF)
Summary: Inhibits inosine monophosphate dehydrogenase, suppressing T and B lymphocyte proliferation for GVHD prevention. Source: Summary of Web Search.
Cellular Therapy: Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT)
Summary: Uses donor stem cells to replace diseased marrow, restoring hematopoiesis and immune function in leukemia/MDS/MPN. Source: Summary of Web Search.
Chemotherapy: Cyclophosphamide
Summary: Alkylating agent that cross-links DNA to prevent replication of malignant and immune cells, used in conditioning and GVHD prevention. Source: FDA label.
Chemotherapy: Fludarabine
Summary: Purine analog inhibiting DNA synthesis via DNA polymerase and ribonucleotide reductase blockade, used in conditioning regimens for leukemia. Source: FDA label.
Radiation Therapy: VMAT-Based Total Marrow and Lymphoid Irradiation (TMLI)
Summary: Delivers targeted radiation to marrow, lymph nodes, and spleen using volumetric modulated arc therapy to intensify leukemia/lymphoma cell kill while sparing organs. Source: Summary of Web Search.

Key Inclusion

Age 18-60 (Cohort A) or 18-70 (Cohort B)
Karnofsky score >= 70%
Receiving allogeneic PBSC graft
HLA typed at high resolution, 8/8, 7/8, or haploidentical donor
AML, MDS, MPN, or MDS/MPN overlap with high-risk features (e.g., TP53 mutation, blast thresholds)
Adequate cardiac, pulmonary, liver, renal function
First allogeneic HCT (Cohort A) or relapse after prior allo HCT (Cohort B)
Voluntary written consent

Key Exclusion

Pregnant or breastfeeding
Untreated active infection
Active HIV with detectable viral load
Active CNS malignancy
GVHD requiring significant systemic therapy
Unsafe medical/psychological condition
Prior radiation deemed unsafe for trial participation

NCT07631598

Buprenorphine Implementation at Syringe Services Programs To Reduce Overdoses: A Type 1 Hybrid Effectiveness-Implementation Trial

Organization/Sponsor: Montefiore Medical Center

Example patient: A 34-year-old English-speaking man with moderate opioid use disorder, currently enrolled at a syringe services program, interested in starting buprenorphine, with no legal restrictions or opioid agonist treatment.

Phase N/A

Interventions

Drug: Low Threshold Buprenorphine
Summary: Partial opioid agonist providing low-barrier access to buprenorphine treatment for opioid use disorder within syringe services programs, unrelated to leukemia/lymphoma treatment. Source: Summary of Web Search.
Behavioral/Referral: Standard of Care Referral
Summary: Conventional referral pathway representing treatment-as-usual comparator; not specific to leukemia/lymphoma care in this trial context. Source: Summary of Web Search.

Key Inclusion

Age 18 or older
Meets DSM-5 criteria for moderate/severe OUD
Interested in buprenorphine treatment
Speaks English or Spanish
Currently an SSP client
Able to provide informed consent

Key Exclusion

Currently on prescribed opioid agonist treatment
Unstable mental health or medical condition requiring immediate care
Allergy to buprenorphine
Currently detained or facing pending legal action preventing 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 English-speaking woman who completed chemotherapy for Hodgkin lymphoma 8 months ago, with no active psychiatric or cognitive issues, seeking support to improve her quality of life.

Phase N/A

Interventions

Behavioral: SMART3RP-Lymphoma
Summary: A mind-body resilience program using stress management and relaxation techniques to help lymphoma survivors adapt to chronic stress and improve quality of life post-treatment. Source: Summary of Web Search.
Behavioral: Health Education Program
Summary: An educational intervention aimed at improving patient understanding and engagement, reducing barriers to care via electronic health tools. Sources: Summary of Web Search; NCI Thesaurus.

Key Inclusion

English or Spanish speaking adults 18+
Within 2 years of completing curative lymphoma treatment
Treatment may include surgery, chemotherapy, immunotherapy, or radiation

Key Exclusion

Active psychiatric comorbidity
Active cognitive comorbidity as determined by PI or clinician

NCT07654426

A Randomized Study of Dexrazoxane or Liposomal Doxorubicin in Newly Diagnosed Diffuse Large B-cell Lymphoma at High Risk for Heart Failure Events: the CARDIOPROTECT Trial Genomic-based

Organization/Sponsor: Beth Israel Deaconess Medical Center

Example patient: A 68-year-old man newly diagnosed with diffuse large B-cell lymphoma with LVEF 45% and no prior chemotherapy, planned for R-CHOP, without CNS involvement or frailty, meets eligibility for randomization.

Phase N/A

Interventions

Antibody-drug conjugate: Polatuzumab Vedotin
Summary: CD79b-directed antibody-drug conjugate delivering MMAE to induce microtubule inhibition and apoptosis in B-cell lymphomas; used with chemo for DLBCL. Source: FDA label.
Monoclonal antibody: rituximab
Summary: Chimeric anti-CD20 monoclonal antibody depleting B cells via cytolytic mechanisms, used in combination chemoimmunotherapy for DLBCL. Source: FDA label.
Corticosteroid: Prednisone
Summary: Synthetic glucocorticoid suppressing inflammation and inducing apoptosis in lymphoid cells; part of CHOP-based regimens. Source: NCI Thesaurus.
Vinca alkaloid chemotherapy: Vincristine
Summary: Disrupts microtubule formation causing mitotic arrest; used as part of CHOP regimen for lymphoma. Source: FDA label.
Alkylating agent: Cyclophosphamide
Summary: Alkylating agent cross-linking DNA to inhibit replication in lymphoma cells; part of CHOP chemotherapy backbone. Source: FDA label.
Anthracycline (liposomal): Liposomal Doxorubicin
Summary: Liposome-encapsulated anthracycline inhibiting topoisomerase II with reduced cardiotoxicity, studied as cardioprotective substitute for doxorubicin. Source: NCI Thesaurus.
Anthracycline: Doxorubicin
Summary: Standard anthracycline intercalating DNA and inhibiting topoisomerase II; core component of R-CHOP, associated with cardiotoxicity risk. Source: FDA label.
Cardioprotectant (placebo): Dexrazoxane placebo
Summary: Placebo control for dexrazoxane arm, used to evaluate cardioprotective efficacy without anticancer activity. Source: Summary of Web Search.
Cardioprotectant: Dexrazoxane
Summary: Topoisomerase II inhibitor and iron-chelating agent that reduces anthracycline-induced cardiotoxicity in high-risk lymphoma patients. Source: Summary of Web Search.

Key Inclusion

Histologically confirmed DLBCL, transformed lymphoma, or high-grade B-cell lymphoma planned for R-CHOP or pola-R-CHP
No prior chemotherapy for this malignancy
Age ≥18 years
At least one HF risk factor: LVEF 30-50%, LVEF ≥50% with HF history, or prior anthracycline exposure
Adequate contraception required for men and women of childbearing potential
Willing and able to provide informed consent

Key Exclusion

NYHA Class III or IV exertional dyspnea due to HF
LVEF <30% on most recent echocardiogram
Frailty per geriatric assessment
History of allergic reaction to similar agents
CNS involvement
Double-hit lymphoma ineligible for intensified induction
Ineligible for R-CHOP/pola-R-CHP due to liver disease
Planned dose-reduced regimen (R-mini-CHOP)

NCT07780097

A Pilot Randomized Controlled Trial to Improve Outpatient Initiation of Medication for Opioid Use Disorder (MOUD) Following Hospitalization: The TRTME (Tailored Overdose Risk Feedback, Testimonials for MOUD Treatment, and Education on MOUD and Opioid Overdose) Trial

Organization/Sponsor: University of Cincinnati

Example patient: A 34-year-old hospitalized adult with opioid use disorder, deemed a good candidate for buprenorphine by the Addiction Consult Team, understands the consent process, and has no pending legal or nursing facility discharge issues.

Phase N/A

Interventions

Behavioral/Educational Intervention: TRTME
Summary: TRTME is a behavioral intervention combining tailored overdose risk feedback, testimonials, and education to improve outpatient initiation of medication for opioid use disorder after hospitalization; the provided description referencing leukemia/lymphoma mechanisms appears inconsistent with this trial's actual behavioral focus (Source: Summary of Web Search).

Key Inclusion

18 years of age or older
Good candidate for methadone or buprenorphine treatment per Addiction Consult Team

Key Exclusion

Planned discharge to a nursing facility
Currently in jail, prison, or inpatient facility per court order
Pending legal action with high probability of incarceration or mandated inpatient treatment
Unable to demonstrate adequate understanding of study procedures during consent

NCT07516353

my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults

Organization/Sponsor: Dana-Farber Cancer Institute

Example patient: A 17-year-old English-speaking patient newly diagnosed with Hodgkin lymphoma, currently receiving alkylator-based chemotherapy at DFCI with curative intent, who consents with guardian approval.

Phase N/A

Interventions

Digital Health Tool: my.naviGATE Digital Tool
Summary: A mobile app providing personalized survivorship education and virtual peer navigation for AYAs with cancer, including leukemia and lymphoma, aiming to improve engagement in risk-informed survivorship care via participant-reported outcomes. Source: Summary of Web Search.

Key Inclusion

Aged 15-24
Actively receiving cancer directed therapy for newly diagnosed cancer
Diagnosis of sarcoma, AML, ALL/lymphoblastic lymphoma, Hodgkin/mature B-cell lymphoma, or medulloblastoma
Treatment includes alkylators, anthracyclines, and/or radiation
Treated at DFCI, CNH, or RPOCH

Key Exclusion

Unwilling to give informed consent/assent
No chance of cure per treating physician
Relapsed or refractory disease
Non-English speaking/reading
Physician requests patient not be approached

NCT07685717

A Phase 2 Trial of Single-Agent Pirtobrutinib for Elderly Patients With CLL

Organization/Sponsor: Ohio State University Comprehensive Cancer Center

Example patient: A 78-year-old man newly diagnosed with treatment-requiring CLL, ECOG 1, normal organ function, no cardiac history, and no prior CLL therapy, eligible for single-agent pirtobrutinib.

Phase 2

Interventions

Drug: Pirtobrutinib
Summary: Oral, non-covalent BTK inhibitor that reversibly binds BTK, blocking B-cell receptor signaling and downstream survival pathways in malignant B-cells; FDA-approved for relapsed/refractory CLL/SLL and MCL after prior therapy (Source: FDA label, NCI Thesaurus).
Other: Questionnaire Administration
Summary: Collects patient-reported outcomes to assess quality of life and treatment impact (Source: NCI Thesaurus).
Other: Electronic Health Record Review
Summary: Review of EHR data to monitor patient outcomes and treatment course (Source: NCI Thesaurus).
Procedure: Computed Tomography
Summary: Imaging technique using X-rays to assess disease burden and treatment response (Source: NCI Thesaurus).
Procedure: Bone Marrow Biopsy
Summary: Tissue sampling from bone marrow to evaluate CLL involvement and disease status (Source: NCI Thesaurus).
Procedure: Bone Marrow Aspiration
Summary: Needle aspiration of marrow to assess hematopoietic disorders and CLL progression (Source: NCI Thesaurus).
Procedure: Biospecimen Collection
Summary: Collection of blood/tissue samples for correlative and research analyses (Source: NCI Thesaurus).

Key Inclusion

Age ≥ 75 years
Diagnosis of CLL/SLL per 2018 iwCLL criteria
Treatment-naive for CLL
Requires treatment per iwCLL guidelines
ECOG performance status ≤ 3
Adequate liver, renal, and coagulation function
Able to take oral medications
Adequate blood counts unless due to marrow involvement

Key Exclusion

Active Richter's transformation
Malabsorption or inability to absorb pirtobrutinib
Significant cardiac disease (heart failure, arrhythmia, recent MI)
QTcF > 470 msec
Recent major surgery or bleeding disorder
Recent stroke or intracranial hemorrhage
HIV, active HBV/HCV, or CMV infection
Requires warfarin or vitamin K antagonist anticoagulation

NCT07751991

A Phase 1/2, Multicenter, First-in-Human, Dose Escalation and Expansion Study Evaluating CHM-029 as Monotherapy in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) With NPM1 Mutations, KMT2A or NUP98 Rearrangements Genomic-based

Organization/Sponsor: Charm Therapeutics

Example patient: A 55-year-old man with relapsed AML harboring an NPM1 mutation, controlled WBC count, normal organ function, and no active infections or cardiac risk factors, seeking further treatment after failing standard therapy.

Phase 1, Phase 2

Interventions

Drug: CHM-029
Summary: CHM-029 is a next-generation menin inhibitor designed to disrupt the menin-KMT2A interaction, targeting leukemic transcriptional programs in AML with NPM1 mutations, KMT2A or NUP98 rearrangements; aims to overcome resistance mutations for deeper responses (Source: Summary of Web Search).

Key Inclusion

Age 18 or older
Relapsed or refractory AML after standard therapies
Positive for NPM1 mutation, KMT2A or NUP98 rearrangement

Key Exclusion

WBC count >25,000/uL uncontrolled by hydroxyurea
Extramedullary only AML
Active complications from prior HSCT
Other cancers requiring treatment
Active Hepatitis or HIV infection
Moderate hepatic or renal impairment
Acute promyelocytic leukemia
Baseline QTc ≥470 ms or CHF NYHA Class 3/4

NCT06789159

A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL) Genomic-based

Organization/Sponsor: University of Kentucky

Example patient: A 55-year-old man with EBV-positive DLBCL refractory to two prior chemoimmunotherapy regimens, ECOG 1, normal organ function, and no CNS involvement or PPI use, seeks enrollment in this trial.

Phase 1b

Interventions

Drug: VK-2019
Summary: VK-2019 is a small-molecule inhibitor targeting EBNA-1 protein to disrupt EBV viral replication, aiming to provide anti-tumor effects in EBV-associated cancers including DLBCL. Source: Summary of Web Search.

Key Inclusion

Age ≥18 years
Relapsed/refractory EBV-positive DLBCL after ≥2 prior regimens
Exhausted standard of care options
Measurable disease per IWG 2007 criteria
ECOG ≤2
Adequate organ function (ANC, hemoglobin, platelets, renal, hepatic)
Prior anti-cancer treatment completed >2 weeks before study
Effective contraception if sexually active

Key Exclusion

Active CNS involvement
Severe cardiopulmonary or psychiatric disease
Use of OATP1B1/1B3 inhibitors or inducers
Use of proton pump inhibitors
Active GVHD or immunosuppressive therapy
Pregnancy or breastfeeding
QTcF >470 ms
Post-Transplant Lymphoproliferative Disease (PTLD)

NCT07451054

Phase 1 Study of Autologous Anti-CD45 CAR T Cells in Combination With CD45 Base Edited HSPCs in Patients With Relapsed or Refractory Hematologic Malignancies Genomic-based

Organization/Sponsor: University of Pennsylvania

Example patient: A 55-year-old man with relapsed diffuse large B-cell lymphoma after two prior therapies and failed commercial CAR T therapy, with good organ function and ECOG 1, no active infections or CNS disease, seeks autologous HSCT-eligible enrollment.

Phase 1

Interventions

Gene-edited cell therapy: CD45BE-HSPC
Summary: Base-edited hematopoietic stem/progenitor cells engineered to lack CD45 epitope recognition, enabling autologous stem cell rescue after CD45-targeted CAR T therapy. Source: Summary of Web Search.
CAR T-cell therapy: CART-45 cells
Summary: Autologous CAR T cells engineered to target CD45, a pan-hematopoietic marker, designed to deplete malignant hematologic cells in relapsed/refractory lymphoma and leukemia. Source: Summary of Web Search.

Key Inclusion

Relapsed/refractory B-cell, T-cell, or Hodgkin lymphoma after ≥2 prior therapies
Failed or ineligible for prior commercial CAR T therapy
Candidate for autologous HSCT
Adequate organ function (renal, hepatic, cardiac, pulmonary)
ECOG performance status 0-1
Age ≥18 years
No active GVHD if prior allogeneic SCT
Signed informed consent

Key Exclusion

Active hepatitis B or C infection
Uncontrolled active infection
Class III/IV cardiac disability
Active CNS involvement
Circulating T-cell malignancy detected by flow cytometry
Active autoimmune disease requiring immunosuppression
Dependence on systemic steroids/immunosuppressants
Pregnant or nursing patients

NCT07424833

A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of APG-3288 in Patients With Relapsed/Refractory Hematological Malignancies

Organization/Sponsor: Ascentage Pharma Group Inc.

Example patient: A 65-year-old man with relapsed mantle cell lymphoma after two prior lines including a BTK inhibitor, ECOG 1, normal organ function, and no active infections or cardiac disease, seeking enrollment in this Phase I APG-3288 trial.

Phase 1

Interventions

Drug: APG-3288
Summary: APG-3288 is a novel BTK-targeted protein degrader (PROTAC) designed to treat relapsed/refractory B-cell malignancies such as CLL/SLL, DLBCL, MCL, WM, MZL, and FL; IND cleared by FDA and China CDE. Source: Summary of Web Search.

Key Inclusion

ECOG ≤1 (Part 1) or ≤2 (Part 2)
Histologically confirmed R/R CLL/SLL, DLBCL, MCL, WM, MZL, or FL
At least 2 prior lines of systemic therapy including BTK inhibitor
Failed or ineligible for established therapies
Measurable disease
Adequate organ and bone marrow function

Key Exclusion

Concurrent anti-cancer therapy
Investigational therapy within 14 days or 5 half-lives
Unresolved toxicities Grade ≥2
Symptomatic CNS metastases
Therapeutic-dose anticoagulants/antiplatelets
Significant cardiac disease
Uncontrolled infection or autoimmune disease
Prior BTK degrader or allogeneic stem cell transplant

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

Example patient: A 34-year-old man with moderate cocaine use disorder, using cocaine 12 days in the past month, seeking treatment, medically stable, with no psychiatric comorbidities, seizure history, or implanted devices.

Phase N/A

Interventions

Device: Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)
Summary: Non-active control stimulation using an H7-coil that mimics active rTMS without inducing therapeutic neural effects; used as a comparator for cognitive-behavioral therapy augmentation in cocaine use disorder. Source: NCI Thesaurus, Web Search Summary.
Device: Active H7-coil repetitive transcranial magnetic stimulation (rTMS)
Summary: Uses magnetic fields to stimulate the medial prefrontal and anterior cingulate cortices, inducing neuroplastic changes to reduce craving and support cognitive-behavioral therapy in cocaine use disorder. Source: NCI Thesaurus, Web Search Summary.

Key Inclusion

Age 22-65
Meets DSM-5 criteria for current moderate/severe cocaine use disorder
Used cocaine at least 9 days in past 28 days
Treatment-seeking
Agrees to moderate alcohol use limits
Women must use effective contraception

Key Exclusion

Current moderate/severe major depressive episode, bipolar, schizophrenia, or psychosis
Significant suicide risk
Seizure history or seizure risk factors
Implanted devices incompatible with TMS/MRI
Pregnant or breastfeeding
Cognitive disorder (MMSE <25)
Moderate to severe heart disease
Legally mandated to SUD treatment

NCT07572929

A Pragmatic Clinical Trial to Prevent Relapse for Myeloid Malignancies With Measurable Disease Prior to Allogeneic Transplant Genomic-based

Organization/Sponsor: Medical College of Wisconsin

Example patient: A 55-year-old man with AML in remission but detectable minimal residual disease by NGS prior to allogeneic transplant, able to consent.

Phase N/A

Interventions

Control: No intervention
Summary: Control arm with no treatment; used to compare relapse outcomes against maintenance therapy in myeloid malignancy transplant patients. Source: NCI Thesaurus.
Drug/Therapy: Maintenance Therapy
Summary: Post-transplant maintenance therapy intended to target residual malignant clones and reduce relapse risk in myeloid malignancies. Source: Summary of Web Search.

Key Inclusion

Age >=18 years at time of transplant
Diagnosis of myeloid malignancy, MDS, MPN, or AML/biphenotypic leukemia
Pre-transplant disease assessment showing measurable disease via flow, NGS, or PCR
Ability to provide informed consent

Key Exclusion

None

NCT07520006

An Open-label, Multicenter Phase 1b/2 Study to Evaluate the Safety and Efficacy of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies

Organization/Sponsor: Nurix Therapeutics, Inc.

Example patient: A 68-year-old man with relapsed CLL previously treated with a BTK inhibitor, ECOG status 1, normal organ function, and no cardiac or CNS disease, eligible for NX-5948 combination therapy.

Phase 1b, Phase 2

Interventions

Small molecule BTK degrader: NX-5948
Summary: Oral chimeric degrader linking a BTK-binding moiety to a cereblon-binding moiety, inducing ubiquitination and proteasome degradation of BTK to block BCR signaling in B-cell malignancies, including resistant mutations; may cross blood-brain barrier. Source: NCI Thesaurus.
Monoclonal antibody (BLA): obinutuzumab
Summary: Glycoengineered anti-CD20 monoclonal antibody enhancing ADCC and apoptosis in CD20-expressing B cells, indicated for CLL and follicular lymphoma. Source: FDA label.
Monoclonal antibody (BLA): rituximab
Summary: Chimeric anti-CD20 monoclonal antibody causing complement- and antibody-dependent cytotoxicity in B-cell malignancies like CLL and non-Hodgkin lymphoma. Source: FDA label.
Small molecule BCL-2 inhibitor: venetoclax
Summary: Oral selective BCL-2 inhibitor that restores apoptosis in leukemic cells by blocking anti-apoptotic BCL-2 signaling; used in CLL/SLL and AML. Source: FDA label.

Key Inclusion

ECOG performance status 0-2
Adequate organ and bone marrow function
Measurable disease by CT per iwCLL
R/R CLL/SLL with prior BTK inhibitor therapy
Previously untreated CLL/SLL meeting iwCLL treatment criteria
Signed informed consent

Key Exclusion

Prolymphocytic leukemia or Richter's transformation
Recent investigational or anticancer therapy
Recent radiotherapy except focal palliative
High-dose systemic corticosteroid use
Prior BTK degrader treatment
Prior BCL-2 inhibitor unless retreatment eligible
CNS lymphoma or leukemia
Recent cardiac or thromboembolic events

NCT06863402

Nemtabrutinib and Pembrolizumab in Patients With Richter Transformation: A Phase II Study

Organization/Sponsor: Roswell Park Cancer Institute

Example patient: A 62-year-old man with CLL who developed biopsy-confirmed Richter transformation DLBCL, ECOG 1, adequate organ function, no prior checkpoint inhibitor therapy, and no active CNS or autoimmune disease, eligible for nemtabrutinib plus pembrolizumab.

Phase 2

Interventions

Drug: Nemtabrutinib
Summary: Reversible BTK inhibitor that blocks B-cell receptor signaling in both wild-type and C481S-mutated BTK, inhibiting malignant B-cell proliferation; used here for Richter transformation. Source: NCI Thesaurus.
Biologic: Pembrolizumab
Summary: Humanized monoclonal antibody blocking PD-1 to restore T-cell mediated antitumor immunity; FDA-approved across multiple malignancies, combined here with nemtabrutinib. Source: FDA label, NCI Thesaurus.
Procedure: Positron Emission Tomography
Summary: Imaging using radioactive tracers to assess metabolic activity and disease response per Cheson criteria. Source: NCI Thesaurus.
Procedure: Computed Tomography
Summary: Cross-sectional X-ray imaging used for disease staging and response assessment. Source: NCI Thesaurus.
Procedure: Bone Marrow Biopsy
Summary: Tissue sampling to evaluate hematologic disease involvement and progression. Source: NCI Thesaurus.
Procedure: Multigated Acquisition Scan
Summary: Nuclear imaging assessing cardiac ejection fraction to monitor cardiotoxicity during treatment. Source: NCI Thesaurus.
Procedure: Echocardiography
Summary: Ultrasound-based cardiac imaging used to assess cardiac function prior to and during treatment. Source: NCI Thesaurus.
Procedure: Biospecimen Collection
Summary: Collection of blood/tissue samples for correlative and biomarker research. Source: NCI Thesaurus.
Other: Questionnaire Administration
Summary: Patient-reported outcome tool assessing quality of life and treatment impact. Source: NCI Thesaurus.

Key Inclusion

Biopsy-proven Richter transformation DLBCL from CLL/SLL
Ineligible for anthracycline-based chemo or progressed after prior RT-DLBCL therapy
Measurable disease by PET/CT, IHC, or flow cytometry
ECOG performance status 0-2
Adequate organ function (ANC, platelets, hemoglobin, liver, renal)
Controlled HIV/HBV/HCV allowed under specific conditions
Age ≥18 years
Willing to use contraception and provide informed consent

Key Exclusion

Prior anti-PD-1/PD-L1 or other checkpoint inhibitor therapy
Recent systemic anti-cancer therapy or radiotherapy
Active CNS metastases or carcinomatous meningitis
Hodgkin-like Richter transformation (RT-cHL)
Active autoimmune disease requiring systemic treatment
Active infection or pneumonitis history
QTc prolongation >450 msec
Pregnant or breastfeeding

NCT07573111

An Open-label, First-in-Human, Single Ascending Dose Study of QUAIL-100 in Pediatric and Young Adult Subjects With High-Risk Acute Leukemias and Myelodysplastic Syndrome Who Have Received a T-cell Receptor (TCR) αβ+ T Cell/CD-19+ B Cell-Depleted Hematopoietic Stem Cell Transplantation

Organization/Sponsor: Laguna Biotherapeutics, Inc.

Example patient: A 12-year-old, 40 kg child with high-risk acute leukemia who received an HLA-partially matched αβ T cell/CD19 B cell-depleted HSCT, achieved full engraftment, has a Lansky score of 80, no GVHD, no organ dysfunction, no implanted devices, and no recent live vaccines or anti-leukemic therapy.

Phase 1

Interventions

Biological: QUAIL-100
Summary: Investigational biological agent studied as a single ascending dose in pediatric and young adult patients with high-risk leukemia or MDS post-HSCT; mechanism undisclosed. Source: Summary of Web Search.

Key Inclusion

Weight >= 10 kg
Received HLA-partially matched related or unrelated donor αβ T cell-depleted HSCT for high-risk malignant disease
Achieved myeloid and platelet engraftment
Lansky/Karnofsky score > 60
Agree to contraception use if of childbearing potential

Key Exclusion

Active Grade II aGVHD requiring >0.5 mg/kg methylprednisolone or Grade III/IV aGVHD
Significant cardiac, pulmonary, renal, hepatic, GI, neurological or immunological disease
Allergy/hypersensitivity to both amoxicillin and gentamycin
Implanted devices with high bacterial seeding risk
Planned anti-leukemic therapy within 21 days of dosing
TNF-alpha or PI3K inhibitor use within 60 days
Prior investigational Listeria product including QUAIL-100
Live attenuated vaccine within 4 weeks of first dose

NCT07514819

Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma

Organization/Sponsor: St. Jude Children's Research Hospital

Example patient: A 12-year-old girl with Hodgkin's lymphoma is scheduled for 15 fractions of proton therapy at St. Jude, has no severe comorbidities, and her guardian provides informed consent.

Phase N/A

Interventions

Radiation Therapy: Proton Therapy (Adaptive)
Summary: Adaptive proton therapy delivers high-energy proton beams precisely to tumors, sparing healthy tissue, and adjusts treatment plans based on ongoing imaging data. Used in pediatric solid tumors and Hodgkin's lymphoma. Source: NCI Thesaurus, Web Search Summary.

Key Inclusion

Diagnosed with solid tumors (Rhabdomyosarcoma, Osteosarcoma, Ewing sarcoma, other sarcomas/carcinomas) or Hodgkin's lymphoma
Receiving proton radiation therapy at St. Jude
Written informed consent obtained

Key Exclusion

Not diagnosed with solid tumor or Hodgkin's lymphoma
Diagnosed with Wilm's tumor or neuroblastoma
Not undergoing proton therapy
Prescribed ≤5 fractions of proton therapy
Severe comorbidities impacting imaging feasibility
Unable to obtain consent
Pregnant or breast-feeding females