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

NCT07563920 | Not Yet Recruiting

• 1 other identifier: SHSYXY-202510-TBF-AML
• Study Type: interventional
• Target: 93
• Locations: 0 countries
• Sites: N/A

Brief 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

Acute Myeloid Leukemia

Keywords

Haploidentical Stem Cell Transplantation; TBF Conditioning Regimen; Thiotepa Busulfan Fludarabine; Elderly AML; Allogeneic Hematopoietic Stem Cell Transplantation; Relapse-Free Survival

Outcome Measures

Primary Outcomes (1)

• 1-year Relapse-Free Survival (RFS)

  Relapse-free survival (RFS) is defined as the time from transplantation to the first occurrence of disease relapse or death from any cause. Patients who are alive without relapse at the last follow-up will be censored.

  12 months after transplantation

Secondary Outcomes (4)

• Overall Survival (OS)

  12 months after transplantation

• Incidence of Acute Graft-Versus-Host Disease (aGVHD)

  Up to 180 days after transplantation

• Incidence of Chronic Graft-Versus-Host Disease (cGVHD)

  12 months after transplantation

• Non-Relapse Mortality (NRM)

  12 months after transplantation

Study Arms (1)

Arms Back to Arms and Interventions * Required * § Required if Study Start Date is on or after Janu

EXPERIMENTAL

Participants will receive a conditioning regimen consisting of thiotepa, busulfan, and fludarabine (TBF) followed by haploidentical peripheral blood stem cell transplantation. Thiotepa is administered on day -7, busulfan on days -4 and -3, and fludarabine on days -6 to -2. Donor stem cells are infused on day 0. Standard graft-versus-host disease prophylaxis and supportive care will be provided according to institutional guidelines.

Drug: Thiotepa; Drug: Busulfan (BU); Drug: Fludarabine; Procedure: Haploidentical Peripheral Blood Stem Cell Transplantation

Interventions

Busulfan (BU) DRUG

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

Arms Back to Arms and Interventions * Required * § Required if Study Start Date is on or after Janu

Fludarabine DRUG

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

Arms Back to Arms and Interventions * Required * § Required if Study Start Date is on or after Janu

Thiotepa DRUG

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.

Arms Back to Arms and Interventions * Required * § Required if Study Start Date is on or after Janu

Haploidentical Peripheral Blood Stem Cell Transplantation PROCEDURE

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.

Arms Back to Arms and Interventions * Required * § Required if Study Start Date is on or after Janu

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Availability of a suitable haploidentical donor
• ECOG performance status 0-2
• Adequate organ function:
• Left ventricular ejection fraction ≥50%
• Oxygen saturation \>92% on room air
• Serum creatinine ≤1.5 × upper limit of normal (ULN)
• Total bilirubin ≤1.5 × ULN
• AST and ALT ≤2.0 × ULN
• DLCO ≥40% and FEV1 ≥50%
• Ability to understand and sign informed consent

You may not qualify if:

• 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
• Active hepatitis B or C requiring antiviral treatment
• Pregnant or breastfeeding women
• Known hypersensitivity to study drugs

Sponsors & Collaborators

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

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Thiotepa; Busulfan; fludarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Xianmin Song

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianmin Song, MD

CONTACT

+86-13501672508; shongxm@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Model Details: All participants receive the TBF conditioning regimen followed by haploidentical peripheral blood stem cell transplantation.

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share