Actively Recruiting
Thiotepa Combined With Busulfan and Fludarabine Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplantation in Elderly Patients With High-Risk Acute Myeloid Leukemia
Led by Peking University People's Hospital · Updated on 2025-05-18
56
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a conditioning treatment regimen combining thiotepa, busulfan, and fludarabine before haploidentical hematopoietic stem cell transplantation (haplo-HSCT) in elderly patients aged 55 to 70 years with high-risk acute myeloid leukemia (AML). This prospective, single-arm, multicenter clinical trial aims to assess the safety and effectiveness of this regimen, focusing on 1-year relapse-free survival as the primary outcome. Participants will receive thiotepa at 5 mg/kg/day on Days -10 and -9, busulfan at 3.2 mg/kg/day on Days -8 to -6, fludarabine at 30 mg/m²/day on Days -6 to -2, and rabbit anti-thymocyte globulin (rATG) at 1.5-2.5 mg/kg/day on Days -5 to -2 as their conditioning regimen. On Day 0, hematopoietic stem cells will be infused. Graft-versus-host disease prevention will involve cyclosporine A, mycophenolate mofetil, and methotrexate. Throughout the study, participants will be closely monitored for relapse-free survival over one year. Evaluations will include survival rates, relapse rates, and non-relapse mortality, with attention to organ function and overall health status. The trial is expected to continue through April 2029, enrolling 56 eligible patients and assessing treatment safety and outcomes over this period.
CONDITIONS
Brief Title
Thiotepa Combined With Busulfan and Fludarabine Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplantation in Elderly Patients With High-Risk Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 55 and 70 years inclusive
- Diagnosis of high-risk acute myeloid leukemia (AML), including relapsed or refractory AML, CR MRD+, or ELN22 adverse risk group
- Scheduled to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT)
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Written informed consent obtained
You will not qualify if you...
- Unwillingness or refusal to accept the study treatment protocol
- Presence of donor-specific anti-HLA antibodies
- Known human immunodeficiency virus (HIV) infection
- Active hepatitis B or C, or chronic active hepatitis
- Uncontrolled active infection at the time of enrollment
- Any other condition deemed unsuitable for study inclusion by the investigator
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 11 days from Day -10 to Day 0
Participants receive a conditioning regimen including thiotepa, busulfan, fludarabine, and rabbit anti-thymocyte globulin followed by hematopoietic stem cell infusion and graft-versus-host disease prophylaxis.
Daily visits during conditioning regimen and stem cell infusion
Duration - Up to 1 year
Participants are monitored for outcomes including relapse-free survival, overall survival, relapse rate, and non-relapse mortality.
Regular follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
Yu Wang MD
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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