Actively Recruiting
VABu Conditioning in Elderly AML HSCT
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-05-14
20
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Soochow University
Lead Sponsor
S
Suzhou Hongci Hematology Hospital, Suzhou, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VABu Conditioning in Elderly AML HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Confirmed diagnosis of acute myeloid leukemia (AML) with intermediate or high-risk prognosis
- Previous positive response to Venetoclax-based therapy
- Planned to undergo allogeneic hematopoietic stem cell transplantation (HSCT)
- Availability of a related donor matched at least 5/10 or an unrelated donor matched at least 8/10 at specified HLA loci
- Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score of 4 or less
- ECOG performance status between 0 and 2
- Adequate organ function including specific kidney, liver, heart, lung, and oxygen levels
- Ability to understand and provide written informed consent
You will not qualify if you...
- Age under 60 years
- Poor response to prior Venetoclax-based therapy
- Unstable systemic diseases such as recent heart attack, severe heart failure, or severe arrhythmia
- Active uncontrolled infection or bleeding in vital organs
- Central nervous system symptoms grade 2 or higher requiring treatment
- Major organ surgery within the past 6 weeks
- History of other malignant diseases within 5 years
- History of thrombosis, embolism, or cerebral hemorrhage within 1 year
- ECOG performance status greater than 2
- Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score greater than 4
- Organ failure as defined by specific criteria
- Known HIV infection or active hepatitis B or C infection
- History of autoimmune disease requiring systemic immunosuppressive therapy
- Pregnancy, breastfeeding, or unwillingness to use effective contraception if of childbearing potential
- Drug abuse or chronic alcoholism
- Psychiatric disorders or other conditions affecting consent or compliance
- Any other condition judged unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
H
Huiying Qiu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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