Can a Triple-Drug cocktail outsmart resistant leukemia?
NCT ID NCT07783100
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a combination of three oral drugs—venetoclax, chidamide, and chiglitazar sodium—can help people with acute myeloid leukemia (AML) that has returned or not responded to previous treatment. The study will enroll about 30 adults with relapsed or refractory AML, including those with secondary or therapy-related forms. Participants will take the three drugs in repeated 28-day cycles, and researchers will measure how many achieve complete remission and how long they live without the disease progressing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of three oral drugs: venetoclax, chidamide, and chiglitazar sodium
- What this could lead to
- If successful, this combination could offer a new treatment option for patients with hard-to-treat AML who have not responded to or relapsed after prior therapy.
- What could go wrong
- This is a small, early-phase study (30 participants) without a comparison group, so results may not be definitive. The drugs can cause side effects, and the combination may not work for everyone.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Nov 2026
An estimate. Start dates often move.
- Expected to finish
-
Nov 2028
An estimate. End dates often move.
- Lead sponsor
-
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
-
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. Histologically confirmed acute myeloid leukemia (AML) with relapsed or refractory disease, including: * Refractory AML, defined as failure to achieve remission after at least one prior treatment; * Relapsed AML, defined as ≥5% blasts in the bone marrow after a previous remission; * AML arising from myelodysplastic syndrome (including CMML) or myeloproliferative neoplasms (secondary AML or therapy-related AML \[t-AML\]) is also eligible. 2. Age ≥18 years, regardless of sex, with an expected survival of \>3 months. 3. Estimated creatinine clearance ≥50 mL/min. 4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × the upper limit of normal (ULN), unless the abnormality is considered attributable to leukemic organ involvement; total bilirubin ≤3.0 × ULN, unless the abnormality is considered attributable to leukemic organ involvement. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 6. Participants must not be pregnant and must agree to use effective contraception during study treatment. 7. Ability to understand the study and willingness to provide written informed consent. Exclusion Criteria: 1. Acute promyelocytic leukemia (APL). 2. Active central nervous system leukemia. 3. Clinically significant cardiovascular disease, including any of the following: * Clinically significant QTc prolongation (QTc \>450 ms in males or \>470 ms in females); * Ventricular tachycardia; * Second-degree atrioventricular block; * Myocardial infarction within 1 year prior to enrollment; * Congestive heart failure; * Coronary artery disease requiring medical treatment. 4. Active, uncontrolled severe infection. 5. Other non-hematologic malignancies within the previous 2 years. 6. Psychiatric disorders that may interfere with participation in the study. 7. Previous solid organ transplantation. Prior stem cell transplantation (SCT) is permitted; however, patients with graft-versus-host disease (GVHD) or those receiving ongoing immunosuppressive or GVHD-directed therapy are not eligible. 8. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Relapsed or refractory acute myeloid leukemia are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
the First affiliated hospital of xiamen university
RECRUITINGXiamen, Fujian, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug take on multiple tough cancers?
- Can a menin-blocking drug outsmart stubborn leukemia?
- New antibody drug takes on tough blood cancers
- New drug BR108 tested in blood cancer patients – early results uncertain
- New hope for tough leukemia: first human trial of KK2845 begins
- Experimental drug cocktail targets relapsed leukemia