Reduced MBF Regimen for Patients Over 50 Years With Myeloid Malignancies

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT05436561

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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 over 50 years.

Condition or Disease	Intervention/Treatment	Phase
Disease-free Survival	Drug: MBF-RIC	Phase 2

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 over 50 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multiple-center Phase II Study to Evaluate the Clinical Outcome of Reduced Conditioning Regimen With Melphalan, Busulfan and Fludarabine for Patients Over 50 Years With Myeloid Malignancies.

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

disease-free survival [2 year]
survival without disease relapse or progression

Secondary Outcome Measures

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.
Non-relapse mortality [2 year]
Death without disease progression or relapse
Relapse [2 year]
disease progression or relapse

Eligibility Criteria

Criteria

Ages Eligible for Study:

51 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 51-65
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Blood & Marrow Transplantation Center, RuiJin Hospital	Shanghai	Shanghai	China	200025
2	Shanghai No 6 Hospital	Shanghai		China

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiong HU, Head, Blood & Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT05436561

Other Study ID Numbers:

MBF-RIC-2022

First Posted:

Jun 29, 2022

Last Update Posted:

Jul 1, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Jul 1, 2022