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

Shanghai Jiao Tong University School of Medicine

Status and phase: Enrolling; Phase 2

Conditions: Disease-free Survival

Treatments: Drug: MBF-RIC

Study type: Interventional

Funder types: Other

Identifiers

NCT05436561

MBF-RIC-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 estimated patients

Sex: All

Ages: 55 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

MBF-RIC

Experimental group

Description:

Patients with MBF-RIC as conditioning regimen

Treatment:

Drug: MBF-RIC