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

NCT07563920 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2026-05-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Thiotepa

Thiotepa is administered intravenously at a dose of 5 mg/kg on day -7 as part of the TBF conditioning regimen prior to haploidentical peripheral blood stem cell transplantation.

DRUG

Busulfan (BU)

Busulfan is administered intravenously at a dose of 3.2 mg/kg on days -4 and -3 as part of the TBF conditioning regimen.

DRUG

Fludarabine

Fludarabine is administered intravenously at a dose of 30 mg/m² daily from day -6 to day -2 as part of the conditioning regimen.

PROCEDURE

Haploidentical Peripheral Blood Stem Cell Transplantation

Haploidentical peripheral blood stem cell transplantation is performed on day 0 following conditioning. Donor stem cells are infused, and standard graft-versus-host disease prophylaxis and supportive care are provided according to institutional protocols.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Xianmin Song · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-06-30
Completion
2030-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07563920 on ClinicalTrials.gov