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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05436561

Enrollment

Registered

2022-06-29

Start date

2022-06-01

Completion date

2027-06-30

Last updated

2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease-free Survival

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 \>=55 years.

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.

Interventions

DRUGMBF-RIC

Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

CONTACTJieling Jiang

jiangjieling66@hotmail.com+8613311986505

CONTACTjiong HU

hj10709@rjh.com.cn+8613764313546

PRINCIPAL_INVESTIGATORJiong Hu

Shanghai Jiao Tong University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026