Actively Recruiting
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
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-05-14
20
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the efficacy and safety of the VABu conditioning regimen in elderly patients aged 60 years and older who have acute myeloid leukemia (AML) and are undergoing allogeneic hematopoietic stem cell transplantation (HSCT). This open-label, multi-center, single-arm study aims to assess important outcomes such as overall response, relapse rates, survival, graft-versus-host disease (GVHD), and virus reactivation rates. Treatment-related toxicities including bone marrow suppression, infections, and organ dysfunction are also monitored. All participants will receive the VABu conditioning regimen before HSCT. This regimen includes Venetoclax taken orally daily from days -10 to -5, Azacitidine given subcutaneously daily from days -10 to -6, a single oral dose of Semustine on day -10, intravenous Cytarabine on day -1, and intravenous Busulfan every 6 hours from days -4 to -2. Dose adjustments may occur based on toxicity and individual tolerance. This treatment period precedes the stem cell transplant procedure. During the study, participants undergo evaluations including monitoring of survival rates at 1 and 2 years post-transplant, incidence of relapse, GVHD occurrence, virus reactivation, and engraftment success at day 30. Safety assessments track treatment-emergent adverse events from the treatment period through 30 days after treatment. Participants are followed closely to measure progression-free survival and other clinical outcomes over time. The total study duration spans from treatment through extended follow-up periods.
CONDITIONS
Brief 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 response to Venetoclax-based therapy
- Planned to undergo allogeneic hematopoietic stem cell transplantation (HSCT)
- Donor matched at least 5/10 (related) or 8/10 (unrelated) at 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 creatinine, liver enzymes, bilirubin, heart function, oxygen saturation, lung function
- 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 disease such as recent heart attack, stroke, severe heart failure, arrhythmia, or pulmonary hypertension
- Active uncontrolled infection or bleeding in vital organs
- Central nervous system symptoms requiring treatment grade 2 or higher
- Major organ surgery within the last 6 weeks
- History of other malignant diseases within 5 years except AML
- 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 meeting specified criteria
- Known HIV, active hepatitis B or C infection
- History of autoimmune disease requiring systemic immunosuppressive therapy
- Pregnancy, breastfeeding, or unwillingness to use effective contraception in patients of childbearing potential
- Drug abuse or chronic alcoholism
- Psychiatric disorder or condition compromising consent or compliance
- Any other condition making the patient unsuitable for study participation per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 days
Participants receive the VABu conditioning regimen prior to hematopoietic stem cell transplantation (HSCT), involving several drugs administered sequentially over approximately 10 days.
Daily visits during the conditioning regimen
Duration - Up to 2 years post-transplantation
Participants are monitored for safety, engraftment, graft-versus-host disease, and survival outcomes after transplantation.
Regular follow-up visits including assessments at Day 30, Day 100, 6 months, 1 year, and 2 years
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.
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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