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

NCT ID: NCT05436561

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Disease-free Survival

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MBF-RIC

Patients with MBF-RIC as conditioning regimen

Group Type EXPERIMENTAL

MBF-RIC

Intervention Type DRUG

Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan

Interventions

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MBF-RIC

Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan

Intervention Type DRUG

Other Intervention Names

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MBF100

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jiong HU

Head, Blood & Marrow Transplantation Center, Rui Jin Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiong Hu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

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Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai No 6 Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jieling Jiang

Role: CONTACT

+8613311986505

jiong HU

Role: CONTACT

+8613764313546

Facility Contacts

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Jiong HU, M.D.,

Role: primary

86-21-64370045

Ling Wang, M.D.,

Role: backup

86-21-64370045

ChunKang Chang

Role: primary

+862164369181

Other Identifiers

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MBF-RIC-2022

Identifier Type: -

Identifier Source: org_study_id

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