VABu drug combination before stem cell transplant in older adults with acute myeloid leukemia
Tests the VABu drug combination before transplant in older adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: VABu Conditioning in Elderly AML HSCT
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 60 or older with acute myeloid leukemia (AML) who are planned for a donor stem cell transplant and responded to earlier venetoclax-based treatment. All receive the VABu regimen before the transplant.
- Age
- 60 years or older
- Sex
- All sexes can join.
- Disease stage
- Acute myeloid leukemia (AML) with intermediate or high-risk prognosis. A donor stem cell transplant must be planned.
- Earlier treatment
- Must have responded to earlier venetoclax-based treatment. Must not have had a poor response to it.
Main reasons for not taking part
- Known HIV, active HBV or active HCV infection
- Active uncontrolled infection or active bleeding in vital organs
- Unstable heart, brain or lung disease
- Another cancer within the last 5 years
- Pregnancy or breastfeeding
Read by machine on 9 November 2026.
Where in China
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT07583888
- Record updated
- 14 May 2026
- Original description
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).Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Poor response to prior Venetoclax-based therapy; Major organ surgery within 6 weeks; Drug abuse or chronic alcoholism; 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 < 60 years; 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.