NCT06954987Not yet recruitingPhase 2

Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell) Transplant and as Maintenance Therapy After Transplant in Patients With Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

A Two Cohort, Randomized, Double-Blind, Placebo-Controlled, Phase II Multi-Center Signal-Finding Study of Venetoclax Combined With Reduced-Intensity Conditioning Followed by Allogeneic Hematopoietic Cell Transplantation Then Venetoclax Maintenance in Adult Patients With Acute Myeloid Leukemia in First Complete Remission: A MyeloMATCH Sub-Study

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

This phase II MyeloMATCH treatment trial compares the effect of adding venetoclax or placebo to reduced intensity conditioning chemotherapy with fludarabine and busulfan or melphalan, with or without total body irradiation, followed by hematopoietic stem cell transplant and either venetoclax or placebo maintenance therapy after transplant, for the treatment of patients with acute myeloid leukemia (AML). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving chemotherapy and total body irradiation before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells. Adding venetoclax to conditioning therapy before, and giving it as maintenance therapy after, a hematopoietic stem cell transplant may be a more effective treatment option than the usual approach in patients with AML.

Status (registry): Not yet recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 244 (estimated)
First submitted: 1 May 2025
Start date: 15 Jan 2027
Primary completion date: 15 May 2028
Lead sponsor: National Cancer Institute (NCI)
Diseases: Acute myeloid leukemia
NCT number: NCT06954987

What you commit to

Study type: Interventional · Phase 2
Planned participants: 244
From 15 Jan 2027 to the primary completion date, 15 May 2028
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Patients must be registered to the Master Screening and Reassessment Protocol (MSRP) and assigned to this protocol by the MATCHBox Treatment Verification Team
STEP 1: History of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria in first complete remission with morphologic complete remission (CR) or CR with incomplete hematologic recovery (CRi) defined as less than 5% bone marrow blasts by morphology with no circulating leukemic myeloblasts and no known extramedullary disease
STEP 1: MRD status by MDNet must have been performed
STEP 1 COHORT 1: Human leukocyte antigen (HLA)-matched donor defined as one of the following:
- Sibling donor must be a 6/6 match at HLA-A and -B (intermediate or higher resolution) and -DRB1 (at high resolution using deoxyribonucleic acid \[DNA\]-based typing)
- Related donor other than sibling must be an 8/8 match for HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing
- Unrelated donor must be an 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing
- Age 40-75 years
STEP 1 COHORT 1: Not recommended for a myeloablative regimen by treating investigator
STEP 1 COHORT 2: Haploidentical or HLA-mismatched unrelated donor defined as one of the following:
- Haploidentical donors: Related donor must be a haploidentical 3/6, 4/6, or 5/6 match at HLA-A and -B (intermediate or higher resolution) and -DRB1 (at high resolution using DNA-based typing)
- HLA-mismatched unrelated donors: Unrelated donor must be a 6/8 or 7/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing, ideally age \< 35
- Age 18-75 years
STEP 1 COHORT 2: Not recommended for a myeloablative regimen by treating investigator
STEP 1: Prior venetoclax therapy is allowed unless there is evidence of progression or no response (failure to achieve remission) to venetoclax-based regimen \< 2 months prior to registration
STEP 1: No prior allogeneic or autologous hematopoietic cell transplantation
STEP 1: Anti-leukemic therapy must be completed more than 14 days prior to registration with the exception of venetoclax
STEP 1: Karnofsky performance status ≥ 60
STEP 1: Total bilirubin \< 2 x upper limit of normal (ULN)
STEP 1: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) \< 3 x upper limit of normal (ULN)
STEP 1: Alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN)
STEP 1: Pulmonary function diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) ≥ 40% and forced expiratory volume (FEV1) ≥ 50%
STEP 1: Calculated (Calc.) creatinine clearance ≥ 40 mL/min/based on the Cockcroft-Gault formula
STEP 1: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required
STEP 1: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
STEP 1: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
STEP 1: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
STEP 1: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
STEP 1: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification. To be eligible for this trial, patients should have ejection fraction ≥ 40% and NYHA functional status class II or better
STEP 1: No history of liver cirrhosis
STEP 1: No history of sinusoidal occlusion syndrome of the liver
STEP 1: No known intolerance or allergy to any protocol-defined agents
STEP 1: No known medical condition causing an inability to swallow oral formulations of agents
STEP 2: Patient has completed the conditioning and transplantation regimens
STEP 2: Patient has no evidence of AML morphologic relapse
STEP 2: Patient does not have flow measurable/minimal residual disease by myeloMATCH central labs (MDNet) testing defined as ≥ 0.1% on day 100+ (between day 80+ and 110+) marrow
STEP 2: Absolute neutrophil count \> 1,000/mcL (confirmed by a lab draw performed on two separate occasions \[\> 2 days apart\])
STEP 2: Platelet count \> 50,000/mcL
STEP 2: AST (SGOT)/ALT (SGPT) \< 3 x upper limit of normal (ULN)
STEP 2: Total bilirubin \< 2 mg/dL x upper limit of normal (ULN)
STEP 2: Calc. creatinine clearance ≥ 40 mL/min/based on the Cockcroft-Gault formula
STEP 2: Patient does not have active/current grade 3-4 acute GVHD
STEP 2: Patient does not have evidence of grade 3 or higher sinusoidal occlusion syndrome/veno-occlusive disease of the liver as defined by European Society for Blood and Marrow Transplantation (EBMT) criteria

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

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