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NCT Number: NCT05436561

Reduced MBF Regimen for Patients >=55 Years With 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.

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Key information

Conditions

Disease-Free Survival

Age range

55 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Blood & Marrow Transplantation Center, RuiJin Hospital, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBF-RIC

Drug

Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan

Other names: MBF100

Primary outcomes

  1. disease-free survival

    Time frame: 2 year

    survival without disease relapse or progression

Secondary outcomes

  1. overall survival

    Time frame: 2 year

    survival

  2. GVHD and relapse free survival

    Time frame: 2 year

    survival without graft failure, without relapse, without III-IV aGVHD and without mod/sev cGVHD.

  3. Non-relapse mortality

    Time frame: 2 year

    Death without disease progression or relapse

  4. Relapse

    Time frame: 2 year

    disease progression or relapse

Study contacts

Contact information is provided by the study sponsor or research team.

Jieling Jiang

CONTACT

[email protected]

+8613311986505

jiong HU

CONTACT

[email protected]

+8613764313546

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 29, 2022
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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