RecruitingPhase 2NCT05436561

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

A Multiple-center Phase II Study to Evaluate the Clinical Outcome of Reduced Conditioning Regimen With Melphalan, Busulfan and Fludarabine for Patients >=55 Years With Myeloid Malignancies.


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

61 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 55 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria2

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

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Interventions

DRUGMBF-RIC

Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan


Locations(2)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, Shanghai Municipality, China

Shanghai No 6 Hospital

Shanghai, China

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NCT05436561


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