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

Phase 2

Recruiting

• Conditions: Disease-free Survival
• Interventions: Drug: MBF-RIC

• Registration Number: NCT05436561
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief 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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MBF-RIC	MBF-RIC	Patients with MBF-RIC as conditioning regimen

Primary Outcome Measures

Name	Time	Method
disease-free survival	2 year	survival without disease relapse or progression

Secondary Outcome Measures

Name	Time	Method
overall survival	2 year	survival
GVHD and relapse free survival	2 year	survival without graft failure, without relapse, without III-IV aGVHD and without mod/sev cGVHD.
Relapse	2 year	disease progression or relapse
Non-relapse mortality	2 year	Death without disease progression or relapse

Trial Locations

Locations (2)

Blood & Marrow Transplantation Center, RuiJin Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai No 6 Hospital; 🇨🇳 Shanghai, China