New drug cocktail aims to stop leukemia relapse after transplant
NCT ID NCT07562568
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding SHR2554 and azacitidine to standard chemotherapy before a stem cell transplant can lower the chance of cancer returning in people aged 15-60 with high-risk or relapsed leukemia or myelodysplastic syndromes. Half the participants will get the new drug combo, while the other half receives standard chemo. The main goal is to see if the combo reduces relapse rates over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR2554 combined with azacitidine
- What this could lead to
- If successful, this combination could reduce the chance of leukemia or MDS returning after a stem cell transplant, improving long-term survival.
- What could go wrong
- This is an early phase 2 trial with only 160 participants, so results may not apply to everyone. The treatment involves strong chemotherapy and transplant, which carry serious risks like infection and graft-versus-host disease.
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 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
Jun 2030
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
-
15 to 60 years
- 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. Age 15-60 years, of either sex. 2. Diagnosis of AML or ALL according to the WHO 2022 criteria, with an indication for allogeneic hematopoietic stem cell transplantation: AML with high-risk genetics at diagnosis (risk stratification per ELN 2022) or relapsed/refractory AML (meeting any of the following: refractory-failure to achieve complete remission (CR) after two cycles of induction chemotherapy; relapse-reappearance of blasts in peripheral blood or bone marrow (≥5%) after first CR, or extramedullary relapse (EMR)). High-risk B-ALL at diagnosis (risk stratification per ELN 2022) or pre-transplant MRD-positive B-ALL. Confirmed T-ALL. History of central nervous system leukemia (CNSL) or pathologically confirmed extramedullary disease (EMD) during AML or ALL. Myelodysplastic neoplasms (MDS): IPSS score intermediate-2 or high; IPSS-R score high or very high; IPSS-M score high or very high. 3. Availability of an appropriate HLA-matched donor. 4. ECOG performance status 0-2. 5. Adequate major organ function, defined as: Left ventricular ejection fraction ≥50%. Pulmonary function: DLCO ≥50% of predicted value. Liver function: ALT/AST ≤3×ULN, total bilirubin ≤2×ULN. Renal function: estimated creatinine clearance (CrCl) ≥60 mL/min. 6. Ability to understand the study and voluntary signed informed consent. Exclusion Criteria: 1. Acute promyelocytic leukemia (APL); 2. Active central nervous system leukemia; 3. Prior allogeneic hematopoietic stem cell transplantation; 4. Prior treatment with any EZH2 inhibitor; 5. Uncontrolled active infection as assessed by the investigator; 6. Myocardial infarction or unstable angina within the previous 6 months; 7. Known hypersensitivity to Zeprumetostat, azacitidine, or any excipient of the mBuCy regimen; 8. Pregnant or breastfeeding women; 9. Any other medical condition that, in the investigator's judgment, would preclude study enrollment.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute lymphoblastic leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
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 Soochow University
Suzhou, Jiangsu, 215006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a p53-Targeting drug boost chemotherapy in Hard-to-Treat blood cancers?
- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Engineered immune cells aim to wipe out stubborn leukemia
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication