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Reduced MBF Regimen for Patients >=55 Years With Myeloid Malignancies

Reduced MBF Regimen for Patients >=55 Years With Myeloid Malignancies

Recruiting
55-65 years
All
Phase 2
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Overview

In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML >=55 years.

Description

Conditioning regimen with double alkylating agents such as busulfan + melphalan or Busulfan + thiotepa have been shown to improve the transplantation outcome in terms of lower relapse rate in various myeloid malignancies. In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML >=55 years.

Eligibility

Inclusion Criteria:

  • Age 55-65
  • patients with HLA-matched sibling donors, 9-10/10 matched unrelated donors or haplo-identical donors.
  • patients with AML in remission, or MDS in any stage, or CMML in any stage
  • inform consent provided

Exclusion Criteria:

  • patients with abnormal liver (>3N), renal (1.5N) or cardiac function
  • patients with active infection

Study details
    Disease-free Survival

NCT05436561

Shanghai Jiao Tong University School of Medicine

26 January 2024

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