TBF Conditioning Regimen for Haploidentical Stem Cell Transplantation in Elderly AML Patients in First Complete Remission

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-75
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

Acute myeloid leukemia (AML) is a serious blood cancer that mainly affects older adults. For patients who achieve their first complete remission (CR1), allogeneic hematopoietic stem cell transplantation (HSCT) may provide a chance for long-term survival. However, relapse after transplantation remains a major challenge.

This study aims to evaluate the effectiveness and safety of a conditioning regimen that combines thiotepa, busulfan, and fludarabine (TBF) before haploidentical peripheral blood stem cell transplantation (haplo-PBSCT) in elderly patients with AML in first complete remission.

Eligible patients will receive the TBF conditioning regimen followed by stem cell transplantation from a partially matched donor. Participants will be followed to assess relapse-free survival, overall survival, transplant-related complications, and infections.

The results of this study may help improve treatment strategies and outcomes for elderly AML patients undergoing transplantation.

Eligibility criteria

Qualifiers

Age 55 to 75 years

Diagnosed with acute myeloid leukemia (AML) based on morphology, immunophenotyping, cytogenetics, or molecular testing

First complete remission (CR1) or complete remission with incomplete hematologic recovery (CRi)

Eligible for haploidentical hematopoietic stem cell transplantation

Disqualifiers

Secondary AML (including AML evolving from myelodysplastic syndrome or therapy-related AML)

Active, uncontrolled infection

Severe uncontrolled systemic disease (e.g., unstable cardiovascular disease, recent stroke, or severe organ dysfunction)

HIV infection

Trial design

Treatments tested in this trial

  • Thiotepa
  • Busulfan (BU)
  • Fludarabine
  • Haploidentical Peripheral Blood Stem Cell Transplantation

Treatment groups

93 Participants
are divided into 1 treatment group

Locations

This trial has no locations