NCT06869265 Thiotepa Combined With Busulfan and Fludarabine Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplantation in Elderly Patients With High-Risk Acute Myeloid Leukemia
| NCT ID | NCT06869265 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University People's Hospital |
| Condition | Acute Myeloid Leukemia (AML) |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 56 participants in total. It began in 2025-05-01 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 55-70 years (inclusive). 2. 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 . 3. Scheduled to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT). 4. Adequate organ function. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 6. Written informed consent obtained. Exclusion Criteria: 1. Unwillingness or refusal to accept the study treatment protocol. 2. Presence of donor-specific anti-HLA antibodies. 3. Known human immunodeficiency virus (HIV) infection. 4. Active hepatitis B or C, or chronic active hepatitis. 5. Uncontrolled active infection at the time of enrollment. 6. Any other condition deemed by the investigator as unsuitable for study inclusion.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06869265 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 70 Years, studying Acute Myeloid Leukemia (AML). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06869265 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06869265 currently recruiting?
Yes, NCT06869265 is actively recruiting participants. Contact the research team at ywyw3172@sina.com for enrollment information.
Where is the NCT06869265 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06869265 clinical trial?
NCT06869265 is sponsored by Peking University People's Hospital. The trial plans to enroll 56 participants.
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