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RECRUITING Not applicable ClinicalTrials.gov

Conditioning Regimen in Elderly AML Patients Receiving Haplo-HSCT.

Sponsor: Peking University People's Hospital • ClinicalTrials.gov ID: NCT06946602

Registry updated: 2026-09-14
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Description

Elderly AML patients receiving conventional chemotherapy have poor prognosis. Allo-HSCT offers better long-term survival than chemotherapy, while high TRM limits its use. Current research focuses more on improving conditioning regimens to reduce TRM. Studies suggest Bu/Flu/Cy/ATG are safer and more effective for elderly AML haplo-HSCT, lowering TRM. However, prospective randomized trials are lacking. This study aims to compare Bu/Flu/Cy/ATG vs. Bu/Cy/ATG to determine if TRM can be reduced in elderly AML undergoing haplo-HSCT.

Interventions

  • Bu/Flu/Cy/ATG (Procedure)
    The Bu/Flu/Cy/ATG conditioning regimen consists of the following components: Ara-C (2 g/m²/day, injected i.v.) on days-10 and-9; Bu (0.8 mg/kg, q6h, injected i.v.) on days -8 to -6; Flu (30 mg/m²/day, injected i.v.) from day-6 to day-2; Cy (1.0 g/m²/day, injected i.v.) on days-5 and-4; and ATG (2.5 mg/kg/day) on days-5 to -2.
  • Bu/Cy/ATG (Procedure)
    The Bu/Cy/ATG conditioning regimen consists of the following components: Ara-C (4 g/m²/day, injected i.v.) on day-9; Bu (0.8 mg/kg, q6h, injected i.v.) on days -8 to -6; Cy (1.8 g/m²/day, injected i.v.) on days-5 and-4; and ATG (2.5 mg/kg/day) on days-5 to -2.

Eligibility criteria

Inclusion Criteria: \- (a)Diagnosed with AML in first complete remission (CR1). (b)Age ≥55 years. (c)Availability of an haploidentical donor, first transplant, no matched sibling or unrelated donor. (d)Willingness to provide written informed consent. Exclusion Criteria: * (a) Uncontrolled active infection. (b) Secondary AML. (c)Refusal to provide informed consent.

Conditions

AML Elderly

Locations

  • Peking University People's Hospital — Beijing, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record