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OncoMatch/Clinical Trials/NCT05010772

Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission

Is NCT05010772 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for acute myeloid leukemia.

Phase 1RecruitingM.D. Anderson Cancer CenterNCT05010772Data as of May 2026

Treatment: Decitabine and Cedazuridine · Enasidenib · Gilteritinib · Ivosidenib · VenetoclaxThis phase Ib trial is to find out the side effects and possible benefits of decitabine alone or given together with venetoclax, gilteritinib, enasidenib, or ivosidenib in treating patients with acute myeloid leukemia that is under control (remission). Chemotherapy drugs, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2 needed for cell growth. Gilteritinib, enasidenib, and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine alone or together with venetoclax, gilteritinib, enasidenib, or ivosidenib may help to control the disease.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Allowed: RUNX1 t(8;21)

Allowed: CBFB inv(16)

Allowed: BCR t(9;22)

Patients with t(9;22) are also ineligible unless they are unable or unwilling to receive therapy with a tyrosine kinase inhibitor

Performance status

ECOG 0–3(Limited self-care)

Prior therapy

Min 1 prior line

Must have received: cytarabine-based therapy (cytarabine) — remission induction and at least 1 consolidation cycle

Patients who have received intensive therapy (defined as receiving standard or higher dose cytarabine-based therapy) to achieve remission (CR/CRi) should have received remission induction therapy and at least 1 consolidation cycle

Must have received: low-dose cytarabine or hypomethylating agent-based therapy (low-dose cytarabine, hypomethylating agent) — at least 2 cycles between CR/CRi and enrollment

Patients who have received lower intensity therapy (defined as receiving low-dose cytarabine [LDAC] or hypomethylating agent [HMA]-based therapy) to achieve remission should have received at least 2 cycles of lower intensity therapy between the time they have achieved CR/CRi and enrollment

Cannot have received: tyrosine kinase inhibitor

Exception: Patients with t(9;22) are ineligible unless unable or unwilling to receive therapy with a tyrosine kinase inhibitor

Patients with t(9;22) are also ineligible unless they are unable or unwilling to receive therapy with a tyrosine kinase inhibitor

Lab requirements

Blood counts

Absolute neutrophil count (ANC) > 0.5 x k/uL; Platelet count >= 50 x k/uL

Kidney function

Serum creatinine <= 2.5 x ULN

Liver function

Serum total bilirubin <= 1.5 x the upper limit of normal (ULN)

Serum total bilirubin <= 1.5 x the upper limit of normal (ULN); Serum creatinine <= 2.5 x ULN; Absolute neutrophil count (ANC) > 0.5 x k/uL; Platelet count >= 50 x k/uL

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

US trial sites

  • M D Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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