NCT07583888 VABu Conditioning in Elderly AML HSCT
| NCT ID | NCT07583888 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Allogeneic Hematopoietic Stem Cell Transplantation Recipient |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-05-07 |
| Primary Completion | 2027-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-05-07 with a primary completion date of 2027-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open-label, multi-center, single-arm clinical study evaluating the efficacy and safety of the VABu conditioning regimen in elderly patients (≥60 years) with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (HSCT). The VABu regimen consists of Venetoclax, Azacitidine, Semustine, Cytarabine, and Busulfan. All enrolled participants will receive the VABu regimen as conditioning therapy prior to HSCT. The study aims to enroll 20 participants from multiple centers in China. The primary objectives are to evaluate the overall response rate, cumulative relapse rate, overall survival, graft-versus-host disease (GVHD)-free relapse-free survival (GRFS), non-relapse mortality (NRM), incidence of acute and chronic GVHD, and reactivation rates of cytomegalovirus (CMV) and Epstein-Barr virus (EBV). Safety outcomes include treatment-related toxicities, such as bone marrow suppression, infection, and organ dysfunction.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07583888 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Allogeneic Hematopoietic Stem Cell Transplantation Recipient. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07583888 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07583888 currently recruiting?
Yes, NCT07583888 is actively recruiting participants. Contact the research team at mumukongxin@hotmail.com for enrollment information.
Where is the NCT07583888 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07583888 clinical trial?
NCT07583888 is sponsored by The First Affiliated Hospital of Soochow University. The trial plans to enroll 20 participants.