Triple-Drug combo aims to stop AML relapse after remission
NCT ID NCT07521124
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether a combination of three drugs (chidamide, venetoclax, and azacitidine) can help prevent acute myeloid leukemia (AML) from coming back in patients who have already achieved remission. About 104 adults aged 18 to 80 will receive up to 12 cycles of treatment. The goal is to see if this maintenance therapy improves relapse-free survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chidamide, venetoclax, and azacitidine
- What this could lead to
- If successful, this maintenance regimen could help keep AML in remission longer and reduce the chance of relapse.
- What could go wrong
- This is an early-phase study with no phase specified, so results are uncertain. The combination may cause side effects and may not improve survival.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 104 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
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 to 80 years
- 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: 1. Patients aged 18 to 80 years with newly diagnosed Acute Myeloid Leukemia (AML) 2. Patients who have achieved their first Complete Remission (CR) or Complete Remission with incomplete hematologic recovery (CRi) at the time of enrollment, following induction therapy with intensive chemotherapy and at least 2 cycles of consolidation therapy. Remission must have been achieved within 4 months (±7 days) prior to enrollment. 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3. 4. Women of childbearing potential are eligible if they meet the following conditions: 1. A negative serum or urine pregnancy test is performed within 10-14 days prior to enrollment, and a second negative pregnancy test is performed within 24 hours prior to the initiation of treatment. Both negative results are required to meet the criteria for treatment initiation. 2. They agree to practice abstinence or use two effective methods of contraception during the treatment period and for 28 days after discontinuation of the study drug. 5. Male patients with female partners of childbearing potential are eligible if they agree to practice abstinence or use two effective methods of contraception during the treatment period and for 28 days after discontinuation of the study drug. 6. Women of childbearing potential must comply with scheduled pregnancy tests. 7. Ability to understand and sign the Informed Consent Form (ICF). Exclusion Criteria: 1. Diagnosis of Acute Promyelocytic Leukemia (APL) or FAB subtype M3 AML. 2. Patients with a history of extramedullary leukemia, unless central nervous system (CNS) involvement is controlled. 3. Laboratory values that do not meet the following criteria: Total Bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); Serum Creatinine ≤ 2.5 × ULN; Absolute Neutrophil Count (ANC) \> 0.5 × 10⁹/L; Platelet Count ≥ 30 × 10⁹/L. 4. Uncontrolled comorbidities, including but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina, arrhythmia, or psychiatric illness/social situations that would compromise compliance with the protocol. 5. History of AML that was refractory to or did not achieve remission with prior treatment containing Venetoclax, Chidamide, or Azacitidine. 6. History of hypersensitivity to any component of the study protocol. 7. Pregnant women. 8. Patients with active Central Nervous System (CNS) disease. 9. Patients with Relapsed or Refractory (R/R) AML. 10. Patients who have undergone Hematopoietic Stem Cell Transplantation (HSCT).
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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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Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog
Wuhan, China
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