VABu Conditioning for elderly AML patients undergoing stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multi-center, single-arm study enrolling about 20 participants aged 60 and older with intermediate to high-risk AML who are planned for allogeneic HSCT. The conditioning combines Venetoclax, Azacitidine, Semustine, Cytarabine, and Busulfan before transplantation. The study will measure response rates, relapse, overall survival, GVHD-free relapse-free survival, non-relapse mortality, GVHD incidence, CMV/EBV reactivation, and safety outcomes like marrow suppression and organ toxicity. Data from multiple centers in China will be analyzed to assess the regimen’s efficacy and safety in this specific population.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Huiying Qiu, M.D.
• Email: mumukongxin@hotmail.com
• Phone: +8618151578096

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.