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Recruiting NCT05436561

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

Phase II Interventional Disease-free Survival

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MBF-RIC.
Who it may be relevant to
Registry conditions: Disease-free Survival. Basic parameters: 55 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

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.

Detailed 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.

Interventions

  • Drug MBF-RIC
    Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan

Primary outcome measures

  • disease-free survival [Time frame: 2 year]
Secondary outcome measures (4)
  • overall survival [Time frame: 2 year]
  • GVHD and relapse free survival [Time frame: 2 year]
  • Non-relapse mortality [Time frame: 2 year]
  • Relapse [Time frame: 2 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Blood & Marrow Transplantation Center, RuiJin Hospital — Shanghai
  • Shanghai No 6 Hospital — Shanghai

Identifiers

NCT: NCT05436561 · MBF-RIC-2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗