Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

Conditions

• Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration
• Decitabine and Cedazuridine — DRUG
  Given PO
• Venetoclax — DRUG
  Given PO

Study Details

This phase II MyeloMATCH treatment trial compares ASTX727 with standard duration versus shorter duration of venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML). ASTX727 is a combination of decitabine and cedazuridine. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. 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. Shorter duration venetoclax may be as effective as standard duration venetoclax when given with ASTX727 for the treatment of newly diagnosed AML.

Key Dates

First listed

Feb 27, 2026

Start date

Apr 18, 2027

Status verified

Aug 2026

Primary completion

Sep 22, 2034

Completion

Sep 22, 2034

Study Design

Enrollment

126 participants (estimated)

Allocation

NA

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1 (ASTX727 with standard duration venetoclax)
  Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or treatment discontinuation. Patients undergo bone marrow aspiration and blood sample collection throughout the study.
• Experimental: Arm 2 (ASTX727 with shorter duration venetoclax)
  Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-14 of each cycle. Cycles repeat every 28 days in the absence of disease progression or treatment discontinuation. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

Primary Outcome Measure

Minimal residual disease (MRD) negative complete remission (CR) [ Time Frame: At 180 days ]

Locations (25)

Find similar trials in Bloomington, IL

Related Studies

• KIR Favorable Mismatched Haplo Transplant and KIR Polymorphism in ALL/AML/MDS Allo-HCT Children
  PHASE2 · Enrolling By Invitation · Michael Pulsipher · Los Angeles, California
• A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
  PHASE1/PHASE2 · Recruiting · Syndax Pharmaceuticals · Aurora, Colorado
• A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
  PHASE2 · Enrolling By Invitation · Taiho Oncology, Inc. · Fountain Valley, California
• A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
  PHASE1 · Recruiting · Seagen, a wholly owned subsidiary of Pfizer · Duarte, California