Thiotepa Combined With Busulfan and Fludarabine Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplantation in Elderly Patients With High-Risk Acute Myeloid Leukemia

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for older patients (aged 55 to 70) with high-risk acute myeloid leukemia (AML), a type of blood cancer that can be difficult to treat. The study will look at the effectiveness and safety of a combination of medications—thiotepa, busulfan, and fludarabine—used before a specific type of stem cell transplant called haploidentical hematopoietic stem cell transplantation (haplo-HSCT). This treatment aims to improve the chances of patients remaining free from cancer after one year.

To participate in this trial, patients must be diagnosed with high-risk AML and have certain qualifying conditions, such as relapsed or treatment-resistant disease. They should also have adequate organ function and be in good enough health to undergo the procedure. During the trial, participants will receive the conditioning treatment over several days, followed by the stem cell transplant. The study will monitor their recovery and response to the treatment. It's important to note that this trial is not yet recruiting participants, and some individuals may be excluded based on specific health criteria.

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ALL

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.