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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05436561
Other study ID # MBF-RIC-2022
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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