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.

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 Overview

• Status: Recruiting
• Conditions: Disease-free Survival
• Intervention / Treatment: Drug: MBF-RIC

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 Type: Interventional
• Enrollment (Estimated): 61
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jieling Jiang; Phone Number: +8613311986505; Email: jiangjieling66@hotmail.com
• Study Contact Backup: Name: jiong HU; Phone Number: +8613764313546; Email: hj10709@rjh.com.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai No 6 Hospital
    • Contact: ChunKang Chang; Phone Number: +862164369181; Email: changchunkang@sjtu.edu.cn
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Blood & Marrow Transplantation Center, RuiJin Hospital
      • Contact: Jiong HU, M.D.,; Phone Number: 86-21-64370045; Email: hujiong@medmail.com.cn
      • Contact: Ling Wang, M.D.,; Phone Number: 86-21-64370045; Email: cclingjar@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBF-RIC; Patients with MBF-RIC as conditioning regimen	Drug: MBF-RIC; Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan; Other Names: MBF100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-free survival	survival without disease relapse or progression	2 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Jiong Hu, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 21, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MBF-RIC-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No