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.
Treatment: Decitabine and Cedazuridine · Enasidenib · Gilteritinib · Ivosidenib · Venetoclax — This 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.
Check if I qualifyExtracted 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
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
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