NCT05436561

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
14mo left

Started Jun 2022

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jun 2022Jun 2027

Study Start

First participant enrolled

June 1, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

June 23, 2022

Last Update Submit

March 15, 2026

Conditions

Disease-free Survival

Outcome Measures

Primary Outcomes (1)

  • disease-free survival

    survival without disease relapse or progression

    2 year

Secondary Outcomes (4)

  • overall survival

    2 year

  • GVHD and relapse free survival

    2 year

  • Non-relapse mortality

    2 year

  • Relapse

    2 year

Study Arms (1)

MBF-RIC

EXPERIMENTAL

Patients with MBF-RIC as conditioning regimen

Drug: MBF-RIC

Interventions

MBF-RICDRUG

Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan

Also known as: MBF100
MBF-RIC

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients with abnormal liver (\>3N), renal (1.5N) or cardiac function
  • patients with active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai No 6 Hospital

Shanghai, China

RECRUITING

Study Officials

  • Jiong Hu

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieling Jiang

CONTACT

+8613311986505jiangjieling66@hotmail.com

jiong HU

CONTACT

+8613764313546hj10709@rjh.com.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Blood & Marrow Transplantation Center, Rui Jin Hospital

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 29, 2022

Study Start

June 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)