New oral combo aims to keep leukemia at bay after remission
NCT ID NCT05010772
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This phase 1 trial tests an oral chemotherapy drug (decitabine) alone or combined with other targeted drugs to prevent acute myeloid leukemia (AML) from coming back in patients who are already in remission. About 125 adults whose AML is under control but who are not ready for a stem cell transplant will take the medication by mouth. The main goal is to check safety and side effects, while also seeing how long patients stay cancer-free.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Decitabine and Cedazuridine (ASTX727), with optional Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib
- What this could lead to
- If successful, this could provide a convenient oral maintenance option to keep AML in remission longer and delay or avoid relapse.
- What could go wrong
- This is an early phase 1 trial focused on safety, so it is too soon to know if it works. Side effects from the drug combinations are possible, and not all patients may benefit.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 125 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Dec 2026
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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * 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 Criteria: * 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
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?