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Decitabine Combinations for AML in Remission

This study is looking at decitabine alone or in combination with venetoclax, gilteritinib, enasidenib, or ivosidenib as a maintenance treatment for acute myeloid leukemia (AML) that is currently in remission (under control). The goal is to see how safe these treatments are and if they can help prevent the cancer from coming back. Decitabine works by stopping cancer cells from growing, while venetoclax, gilteritinib, enasidenib, and ivosidenib may block proteins or enzymes that cancer cells need to grow. You might be able to join if you are 18 or older, have AML in its first remission, and are not immediately getting a stem cell transplant. The study aims to enroll 125 participants, but its current status is unclear.

Study design
This is an interventional study with an unclear phase, planning to enroll 125 participants. It is designed to assess the safety and potential benefits of different drug combinations.
What's involved
Participants will receive oral medication daily for a few days, with treatments repeating every 28 days for up to 4 weeks, as long as the disease doesn't worsen or side effects are too severe.
Compensation
Not stated in the trial record.
Follow-up
The study will measure adverse events (side effects) for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05010772

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~125 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Decitabine and CedazuridineEnasidenibGilteritinibIvosidenibVenetoclax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 5 years

Conditions

Acute Myeloid Leukemia

Explore related trials

Acute Myeloid Leukemia

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Tapan M Kadia, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Tapan M. Kadia, MD
[email protected]
713-792-7305
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients aged \>= 18 years AML who have achieved their FIRST complete response (CR) or complete response with incomplete bone marrow recovery (CRi) and are not immediately candidates for allogeneic stem cell transplant
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. These patients are eligible as long as they are not greater than 2 months from their last consolidation therapy and will be designated as COHORT 1 (intensive induction cohort)
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 on this protocol. They will be designated as COHORT 2 (lower intensity induction cohort)
For either subgroup (lower or higher intensity), patients who have measurable residual disease may be enrolled on their respective cohort at any time without maximum 'time from consolidation' requirement
Eastern Cooperative Oncology Group (ECOG) performance status of \< or = 3
Serum total bilirubin \< or = to 1.5 x the upper limit of normal (ULN)
Serum creatinine \< or = to 2.5 x ULN
Absolute neutrophil count (ANC) \> 0.5 x k/uL
Platelet count \> or = 50 x k/uL
For females of childbearing age, they may participate if they:
Have a negative serum or urine pregnancy test within 10 to 14 days of enrolling
Agree to either abstinence or 2 effective contraceptive methods (such as barrier methods or hormonal contraception) throughout the treatment period and up to 30 days after discontinuing treatment
For male patients with a female partner of childbearing age, they may participate if they agree to either abstinence or 2 effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment
Ability to understand and sign informed consent

Exclusion

Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by French-American-British (FAB) classification based on morphology, immunophenotype, molecular, or cytogenetics studies
Diagnosis of AML associated t(15;17) or APL variant. Patients with t(9;22) are also ineligible unless they are unable or unwilling to receive therapy with a tyrosine kinase inhibitor
Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients with active CNS (central nervous system) disease
Patients with documented hypersensitivity to any components of the study program
Females who are pregnant or lactating or intending to become pregnant during the study
Patients with history of extramedullary AML, except for CNS involvement that is currently controlled, will not be eligible for enrollment
Patient should be removed from current trial if they wish to participate and get treatment on another trial

What this trial measures

  • Incidence of adverse eventsUp to 5 years

    Safety analyses in general will be descriptive and will be presented in tabular format with the appropriate summary statistics. Adverse events will be tabulated using frequency and percentage by severity and by relations to the treatments for each arm.