New drug cocktail aims to boost stem cell transplant success in elderly leukemia patients
NCT ID NCT07583888
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of five drugs (VABu) given before a stem cell transplant in people aged 60 and older with acute myeloid leukemia (AML). The goal is to see if this approach can help control the disease and improve survival. About 20 participants will receive the treatment and be monitored for side effects and outcomes like relapse 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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
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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60 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: 1. Age ≥ 60 years. 2. Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO classification, with intermediate or high-risk prognosis. 3. Previous response to Venetoclax-based therapy. 4. Planned to undergo allogeneic hematopoietic stem cell transplantation (HSCT). 5. Donor availability: Related donor matched at least 5/10 at HLA-A, -B, -C, -DQB1, and -DRB1; OR unrelated donor matched at least 8/10 at the same loci. 6. Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 4. 7. ECOG performance status 0-2. 8. Adequate organ function as defined by: Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 45 mL/min (Cockcroft-Gault formula or 24-hour urine collection); AST ≤ 3.0 × ULN and ALT ≤ 3.0 × ULN; Total bilirubin ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) \> 50%; Baseline oxygen saturation \> 92%; DLCO ≥ 40% and FEV1 ≥ 50%; 9. Ability to understand and provide written informed consent. Exclusion Criteria: 1. Age \< 60 years. 2. Poor response to prior Venetoclax-based therapy. 3. Unstable systemic disease (unstable angina, myocardial infarction, cerebrovascular accident within 3 months; NYHA Class III-IV heart failure; severe arrhythmia; pulmonary hypertension). 4. Active uncontrolled infection or active bleeding in vital organs. 5. CNS symptoms grade ≥ 2 requiring treatment. 6. Major organ surgery within 6 weeks. 7. History of malignant disease other than AML within 5 years. 8. History of thrombosis, embolism, or cerebral hemorrhage within 1 year. 9. ECOG performance status \> 2. 10. HCT-CI score \> 4. 11. Organ failure meeting specified criteria. 12. Known HIV, active HBV, or active HCV infection. 13. History of autoimmune disease requiring systemic immunosuppressive therapy. 14. Pregnancy, breastfeeding, or unwillingness to use effective contraception in patients of childbearing potential. 15. Drug abuse or chronic alcoholism. 16. Psychiatric disorder or other condition compromising informed consent or compliance. 17. Any other condition making the patient unsuitable for study participation in the investigator's judgment.
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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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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a liposomal drug combo improve AML treatment for older adults?
- Can a CDK8/CDK19 blocker help when leukemia and MDS return?
- Can an Anti-Inflammation drug make AML chemotherapy work better?
- Can a new drug trio overcome venetoclax resistance in leukemia?
- Vitamin a boost before stem cell transplant may shield the gut
- Can engineered cells beat relapsed blood cancers?