Tests a transplant preparation regimen in older adults with high-risk leukemia
Tests a drug combination before transplant in older adults with high-risk leukemia.
Plain-language title generated from the registry record
Registry title: Thiotepa Combined With Busulfan and Fludarabine Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplantation in Elderly Patients With High-Risk Acute Myeloid Leukemia
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
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 people aged 55 to 70 with high-risk acute myeloid leukemia who are scheduled for a haploidentical stem cell transplant. It tests a conditioning drug combination given before the transplant.
- Age
- 55 to 70 years
- Sex
- All sexes can join.
- Disease stage
- High-risk acute myeloid leukemia (AML): relapsed or refractory AML, remission with measurable residual disease (CR MRD+), or ELN22 adverse risk group.
- Earlier treatment
- Must be scheduled for a haploidentical hematopoietic stem cell transplant.
Main reasons for not taking part
- Donor-specific anti-HLA antibodies
- Known HIV infection
- Active hepatitis B or C, or chronic active hepatitis
- Uncontrolled active infection at enrollment
- Unwilling to accept the study treatment
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 70 years old?
Source: NCT06869265, who can take part
Where in China
- Peking University People's HospitalBeijing, ChinaContact: Yu WangTaking 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
- Peking University People's Hospital
- Trial code
- NCT06869265
- Record updated
- 18 May 2025
- Original description
Abstract:Read full original descriptionShow less
A Multicenter, Single-Arm, Prospective Clinical Study of Thiotepa Combined With Busulfan and Fludarabine Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplantation in Elderly Patients With High-Risk Acute Myeloid Leukemia
Abstract:
This clinical study is designed to evaluate the efficacy and safety of a thiotepa, busulfan, and fludarabine (TBF) conditioning regimen for haploidentical hematopoietic stem cell transplantation (haplo-HSCT) in elderly patients (≥55 years) with high-risk acute myeloid leukemia (AML). A total of 56 eligible patients will be enrolled in this prospective, single-arm, multicenter trial.
Study Design:
This is a multicenter, single-arm, prospective clinical trial. Eligible patients will receive the following conditioning regimen: thiotepa 5 mg/kg/day on Days -10 to -9; busulfan 3.2 mg/kg/day on Days -8 to -6; fludarabine 30 mg/m²/day on Days -6 to -2; and rabbit anti-thymocyte globulin (rATG) 1.5-2.5 mg/kg/day on Days -5 to -2. Hematopoietic stem cell infusion will be performed on Day 0. Graft-versus-host disease (GVHD) prophylaxis will include cyclosporine A (CsA), mycophenolate mofetil (MMF), and methotrexate (MTX). The primary endpoint of this study is 1-year relapse-free survival (RFS).
Inclusion Criteria:
Age 55-70 years (inclusive). Diagnosis of high-risk AML , include relapsed/refractory AML or CR MRD+ or ELN22 adverse risk group .Relapsed/refractory AML defined as at least one of the following: recurrence of leukemia cells in peripheral blood or bone marrow blasts >5% after complete remission (CR), failure to achieve remission after two courses of standard induction therapy, relapse within 12 months after consolidation therapy, relapse after 12 months that is refractory to conventional chemotherapy, multiple relapses, or persistent extramedullary leukemia）.
Scheduled to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT).
Adequate organ function. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Written informed consent obtained.
Exclusion Criteria:
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 by the investigator as unsuitable for study inclusion.
Inclusion: Age 55-70 years (inclusive); Diagnosis of high-risk AML , include relapsed/refractory AML or CR MRD+ or ELN22 adverse risk group . Relapsed/refractory AML defined as at least one of the following: recurrence of leukemia cells in peripheral blood or bone marrow blasts >5% after complete remission (CR), failure to achieve remission after two courses of standard induction therapy, relapse within 12 months after consolidation therapy, relapse after 12 months that is refractory to conventional chemotherapy, multiple relapses, or persistent extramedullary leukemia ; Scheduled to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT); Adequate organ function; Eastern Cooperative Oncology Group (ECOG) performance status ≤2; Written informed consent obtained.
Exclusion: 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 by the investigator as unsuitable for study inclusion; Unwillingness or refusal to accept the study treatment protocol.