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OncoMatch/Clinical Trials/NCT06511882

Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD

Is NCT06511882 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Azacitidine and Decitabine for acute myeloid leukemia.

Phase 2RecruitingH. Lee Moffitt Cancer Center and Research InstituteNCT06511882Data as of May 2026

Treatment: Azacitidine · Decitabine · VenetoclaxThe purpose of this research study is to see if people whose Acute myeloid leukemia (AML) is being successfully treated with azacitidine or decitabine in combination with venetoclax can discontinue this chemotherapy for some period of time after a year of treatment without increasing the likelihood that their AML will return.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Excluded: TP53 mutation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: hypomethylating agent (azacitidine, decitabine) — frontline

Currently on frontline therapy with HMA (azacitidine or decitabine)/VEN and achieved Complete Remission (CR)/Complete Remission with incomplete marrow recovery (CRi) with MRD negativity

Must have received: BCL2 inhibitor (venetoclax) — frontline

Currently on frontline therapy with HMA (azacitidine or decitabine)/VEN and achieved Complete Remission (CR)/Complete Remission with incomplete marrow recovery (CRi) with MRD negativity

Cannot have received: cytotoxic chemotherapeutic agent

Exception: hydroxyurea prior to achieving CR/CRi is allowed

Use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of AML within 28 days, or 5 half-lives, at the start of the study. Only patients who are receiving frontline HMA (azacitidine or decitabine)/VEN are potentially eligible, but if they had received a course of hydroxyurea prior to achieving CR/CRi, this is allowed.

Cannot have received: experimental agent

Use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of AML within 28 days, or 5 half-lives, at the start of the study.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Moffitt Cancer Center · Tampa, Florida

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