NCT07572695Not yet recruiting
Salvage Haploidentical HSCT With DLI and Targeted Therapy for R/R AML
Salvage Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation Combined With Post-transplant Relapse Prevention Strategies for Relapsed/Refractory Acute Myeloid Leukemia (AML): A Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
This is a prospective, single-center, observational study to evaluate the efficacy and safety of salvage haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) combined with post-transplant relapse prevention strategies in patients with relapsed/refractory acute myeloid leukemia (R/R AML). Eligible patients are adults aged 18-65 years with active AML (bone marrow blasts \>5% or extramedullary disease) and HCT-CI score ≤5. All patients will receive a uniform conditioning regimen consisting of fludarabine, busulfan, and MECCNU, with addition of targeted agents (such as sorafenib, midostaurin, or venetoclax) according to mutation status. Graft-versus-host disease (GVHD) prophylaxis includes reduced-dose ATG (6 mg/kg), FK506, MMF, and basiliximab. Post-transplant maintenance with targeted therapy or azacitidine and prophylactic donor lymphocyte infusion (DLI) will be administered to reduce relapse risk. The primary endpoints are cumulative incidence of relapse (CIR), overall survival (OS), and progression-free survival (PFS). Secondary endpoints include incidence of acute and chronic GVHD, CMV/EBV reactivation, non-relapse mortality (NRM), and GVHD-free, relapse-free survival. Patients will be followed for 24 months after transplantation. This study aims to explore an optimized transplant strategy to improve long-term survival in this high-risk population.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 3 May 2026
- Start date
- 30 Apr 2026
- Primary completion date
- Jun 2026
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07572695
What you commit to
- Study type: Observational
- Planned participants: 40
- From 30 Apr 2026 to the primary completion date, Jun 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Bone marrow blasts ≤5% without extramedullary disease before transplantation Age \<18 years or \>65 years HCT-CI score \>5 Patients with other diagnoses besides AML
Who the study is looking for
- Signed and dated informed consent Willing and able to comply with all study procedures and follow-up Adults aged 18 to 65 years Diagnosis of acute myeloid leukemia (AML) Active disease before transplantation, defined as bone marrow blasts \>5% or presence of extramedullary disease HCT-CI (Hematopoietic Cell Transplantation-Comorbidity Index) score ≤5
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.