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

Disease-free Survival Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05436561
• Other study ID #: MBF-RIC-2022
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: October 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jieling Jiang
• Phone: +8613311986505
• Email: jiangjieling66[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: January 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease-free Survival
• Neoplasms

Intervention

Drug:
• MBF-RIC
Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan

Locations

Country	Name	City	State
China	Blood & Marrow Transplantation Center, RuiJin Hospital	Shanghai	Shanghai
China	Shanghai No 6 Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival	survival without disease relapse or progression	2 year
Secondary	overall survival	survival	2 year
Secondary	GVHD and relapse free survival	survival without graft failure, without relapse, without III-IV aGVHD and without mod/sev cGVHD.	2 year
Secondary	Non-relapse mortality	Death without disease progression or relapse	2 year
Secondary	Relapse	disease progression or relapse	2 year