NCT07583888RecruitingPhase 2/3
VABu Conditioning in Elderly AML HSCT
Efficacy and Safety of the VABu Conditioning Regimen in Elderly Patients With Acute Myeloid Leukemia Undergoing Hematopoietic Stem Cell Transplantation: An Open-Label, Multicenter, Single-Arm Clinical Study
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 7 May 2026
- Start date
- 7 May 2026
- Primary completion date
- 15 Aug 2027
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07583888
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 20
- From 7 May 2026 to the primary completion date, 15 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Poor response to prior Venetoclax-based therapy.
- Major organ surgery within 6 weeks.
- Drug abuse or chronic alcoholism.
Other illness
- Unstable systemic disease (unstable angina, myocardial infarction, cerebrovascular accident within 3 months; NYHA Class III-IV heart failure; severe arrhythmia; pulmonary hypertension).
- Active uncontrolled infection or active bleeding in vital organs.
- History of malignant disease other than AML within 5 years.
- History of thrombosis, embolism, or cerebral hemorrhage within 1 year.
- Organ failure meeting specified criteria.
- Known HIV, active HBV, or active HCV infection.
- History of autoimmune disease requiring systemic immunosuppressive therapy.
- Psychiatric disorder or other condition compromising informed consent or compliance.
- Any other condition making the patient unsuitable for study participation in the investigator's judgment.
Age
- Age \< 60 years.
Other
- CNS symptoms grade ≥ 2 requiring treatment.
- ECOG performance status \> 2.
- HCT-CI score \> 4.
- Pregnancy, breastfeeding, or unwillingness to use effective contraception in patients of childbearing potential.
Who the study is looking for
- Age ≥ 60 years.
- Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO classification, with intermediate or high-risk prognosis.
- Previous response to Venetoclax-based therapy.
- Planned to undergo allogeneic hematopoietic stem cell transplantation (HSCT).
- 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.
- Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 4.
- ECOG performance status 0-2.
- 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%；
- Ability to understand and provide written informed consent.
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.