Reduced MBF Regimen for Patients >=55 Years With Myeloid... | NCT05436561

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

NCT05436561

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Recruiting

Last Update Posted

Mar 17, 2026Actual

Enrollment

61Estimated

Phase

Phase 2

Conditions

Disease-free Survival

Interventions

MBF-RIC

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Jun 23, 2022

First Submission Date that Met QC Criteria

Jun 23, 2022

First Posted Date

Jun 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2026

Last Update Posted Date

Mar 17, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiong HU, Head, Blood & Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MBF-RIC	Experimental	Patients with MBF-RIC as conditioning regimen	Drug: MBF-RIC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MBF-RIC	Drug	Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan	MBF-RIC

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
overall survival	survival	2 year
GVHD and relapse free survival	survival without graft failure, without relapse, without III-IV aGVHD and without mod/sev cGVHD.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jieling Jiang	Contact	+8613311986505		jiangjieling66@hotmail.com
jiong HU	Contact	+8613764313546		hj10709@rjh.com.cn

Overall Officials

Name	Affiliation	Role
Jiong Hu	Shanghai Jiao Tong University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Blood & Marrow Transplantation Center, RuiJin Hospital	Recruiting	Shanghai	Shanghai Municipality	200025	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided