NCT05436561

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 55 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Disease-free Survival

Interventions

Type	Name	Description
DRUG	MBF-RIC	Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan

Timeline

• Start date: 2022-06-01
• Primary completion: 2026-12-01
• Completion: 2027-06-30
• First posted: 2022-06-29
• Last updated: 2026-03-17

Locations

2 sites across 1 country: China