Reduced Intensity Conditioning Regimens for Acute Myeloid Leukemia and Myelodysplastic Syndrome

NCT05674539 · tracked via the Priya Life Science China tracker

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Phase

Phase 3

Started

2023-02-15

Last updated

2025-02-10

Condition(s) studied

Acute Myeloid Leukemia, AdultMyelodysplastic Syndrome(MDS)Allogeneic Hematopoietic Stem Cell Transplantation

Investigational drug(s) / intervention(s)

Fludarabine and BusulfanFludarabine and Melphalan

Fludarabine and Busulfan: Fludarabine with total dose of 150 mg/m\^2 in combination with Busulfan with total dose of 6.4 mg/kg

Fludarabine and Melphalan: Fludarabine with total dose of 150 mg/m\^2 in combination with Melphalan with total dose of 140 mg/m\^2

Study summary

The goal of this clinical trial is to compare outcomes of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation (HSCT) for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients. The main questions it aims to answer are:

* The safety of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years.
* The efficacy of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years.

Participants will be randomized to one of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan)

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age equal or more than 18 years old. * Patients diagnosed with AML or MDS. * Patients who have related or unrelated bone marrow or peripheral blood donors and plan to undergo hematopoietic stem cell transplantation. * Hct-specific complication index score (HCT-CI) more than or equal to 3 or the age of Patients ≥55 years. * Sign the informed consent, promise to abide by the research procedures, and cooperate with the implementation of the whole process of the research. Exclusion Criteria: * Patients with central nervous system involvement. * Patients with HIV seropositive. * Patients with other serious diseases and a life expectancy of less than six months * Patients with severe mental or psychological disorders. * Patients without written informed consent.

Primary outcome measure(s)

Progression-Free Survival (PFS) — 18 months post-randomization
Survival without relapse or progression of the primary disease. Kaplan-Meier (KM) method was used to estimate median PFS.

Trial sites (1)

Facility	City	Region	Status
Wuhan Union Hospital, Tongji Medical college, Huazhong University of Science and Technology	Wuhan	Hubei

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05674539 on ClinicalTrials.gov ↗ ← All trials in China