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

26. april 2026 opdateret af: Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

A Single-Center, Prospective, Single-Arm Clinical Study Evaluating the Efficacy and Safety of Thiotepa, Busulfan, and Fludarabine (TBF) Conditioning Regimen in Haploidentical Peripheral Blood Stem Cell Transplantation for Elderly Acute Myeloid Leukemia Patients in First Complete Remission

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy with increasing incidence in older populations. Despite achieving first complete remission (CR1) after induction chemotherapy, elderly patients remain at high risk of relapse and have poor long-term outcomes.

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is considered a potentially curative treatment for AML. With the development of reduced-intensity conditioning regimens and haploidentical transplantation strategies, more elderly patients are now eligible for transplantation. However, relapse after transplantation remains a major limitation.

The conditioning regimen plays a critical role in determining transplant outcomes. The combination of thiotepa, busulfan, and fludarabine (TBF) has been proposed to enhance anti-leukemic activity while maintaining acceptable toxicity. Previous retrospective and registry-based studies suggest that TBF conditioning may reduce relapse risk compared with conventional regimens, but prospective data in elderly AML patients, especially in Asian populations, remain limited.

This study is a single-center, prospective, single-arm clinical trial designed to evaluate the efficacy and safety of the TBF conditioning regimen in elderly AML patients in first complete remission undergoing haploidentical peripheral blood stem cell transplantation (haplo-PBSCT).

Eligible patients aged 55-75 years with AML in CR1 or CRi will receive a conditioning regimen consisting of thiotepa (day -7), busulfan (days -4 and -3), and fludarabine (days -6 to -2), followed by infusion of donor stem cells on day 0.

The primary endpoint is 1-year relapse-free survival (RFS), defined as the time from transplantation to relapse or death from any cause. Secondary endpoints include overall survival, incidence of acute and chronic graft-versus-host disease (GVHD), non-relapse mortality, hematopoietic engraftment, donor chimerism, and infection rates.

Participants will be followed regularly after transplantation with clinical assessments, laboratory tests, and bone marrow evaluations according to protocol-defined schedules.

The findings from this study are expected to provide prospective evidence for the use of TBF conditioning in elderly AML patients and support optimization of transplantation strategies in this population.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

93

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arms Back to Arms and Interventions * Required * § Required if Study Start Date is on or after Janu
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.
Medicin: 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.
Medicin: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
1-year Relapse-Free Survival (RFS)
Tidsramme: 12 months after transplantation
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 12 months after transplantation
Overall survival is defined as the time from transplantation to death from any cause. Patients alive at last follow-up will be censored.
12 months after transplantation
Incidence of Acute Graft-Versus-Host Disease (aGVHD)
Tidsramme: Up to 180 days after transplantation
The cumulative incidence of grade I-IV and grade III-IV acute graft-versus-host disease within 180 days after transplantation, assessed according to standard criteria.
Up to 180 days after transplantation
Incidence of Chronic Graft-Versus-Host Disease (cGVHD)
Tidsramme: 12 months after transplantation
The cumulative incidence of all-grade and moderate-to-severe chronic graft-versus-host disease, assessed according to NIH consensus criteria.
12 months after transplantation
Non-Relapse Mortality (NRM)
Tidsramme: 12 months after transplantation
Non-relapse mortality is defined as death without evidence of disease relapse. Relapse is treated as a competing event.
12 months after transplantation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Efterforskere

  • Ledende efterforsker: Xianmin Song, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2029

Studieafslutning (Anslået)

1. juni 2030

Datoer for studieregistrering

Først indsendt

26. april 2026

Først indsendt, der opfyldte QC-kriterier

26. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SHSYXY-202510-TBF-AML

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared due to patient privacy concerns and institutional data protection policies. De-identified data may be available from the corresponding investigator upon reasonable request and with appropriate institutional approvals.

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