Can a drug combo stop AML from coming back?
NCT ID NCT04062266
First seen Jun 24, 2026 · Last updated Jul 17, 2026 · Updated 3 times
Summary
This phase II trial tests whether a combination of two drugs, azacitidine and venetoclax, can help keep acute myeloid leukemia (AML) in remission after initial treatment. The study enrolls 50 adults whose AML is in first remission but who are not ready for a stem cell transplant. Participants receive the drugs as maintenance therapy, and researchers track how long they stay relapse-free and monitor for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- azacitidine and venetoclax
- What this could lead to
- If successful, this combination could help keep AML in remission longer, delaying or preventing relapse after initial treatment.
- What could go wrong
- This is a small, early-phase (phase II) study with only 50 participants. The drugs may cause serious side effects, and it is not yet known if they will improve long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
-
Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients aged \>/= 18 years AML who have achieved their FIRST CR or CRi and are not immediately candidates for allogeneic stem cell transplant. 2. 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 enrolled in COHORT 1. 3. 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 treated on COHORT 2. 4. 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. 5. ECOG performance status of \< or = 3 6. Adequate organ function as follows: 1. Serum total bilirubin \< or = to 1.5 X the Upper Limit of Normal (ULN) 2. Serum creatinine \< or = to 2.5 x ULN 7. Adequate BM reserve: 1. Absolute neutrophil count (ANC) \> 0.5 x k/uL 2. Platelet count \> or = 30 x k/uL 8. For females of childbearing age, they may participate if they: 1. Have a negative serum or urine pregnancy test within 10 to 14 days of enrolling 2. 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. 9. 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. 10. Ability to understand and sign informed consent. Exclusion Criteria: 1. Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by FAB classification based on morphology, immunophenotype, molecular, or cytogenetic s studies. 2. 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. 3. 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. 4. Patients with active CNS (central nervous system) disease. 5. Patients with documented hypersensitivity to any components of the study program. 6. Females who are pregnant or lactating or intending to become pregnant during the study. 7. Patients with history of extramedullary AML, except for CNS involvement that is currently controlled, will not be eligible for enrollment. 8. Patient should be removed from current trial if they wish to participate and get treatment on another trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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