Thiotepa, busulfan, and fludarabine treatment for elderly patients with high-risk acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the safety and efficacy of a conditioning regimen involving thiotepa, busulfan, and fludarabine for haploidentical hematopoietic stem cell transplantation in elderly patients aged 55 and older with high-risk acute myeloid leukemia. The trial is a multicenter, single-arm, prospective study that aims to enroll 56 eligible patients. Participants will receive a specific treatment regimen followed by stem cell infusion, with the primary goal of assessing 1-year relapse-free survival rates.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yu Wang MD
• Email: ywyw3172@sina.com
• Phone: 86-8832666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.