Flu-Bu-Mel Conditioning Regimen for Myeloid Disease | NCT04269811

Studies
Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

NCT04269811

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Completed

Last Update Posted

Oct 25, 2023Actual

Enrollment

49Actual

Phase

Phase 2

Conditions

Relapse Rate After Allo-HSCT

Interventions

Flu-Bu-Mel

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2020Actual

Primary Completion Date

Mar 30, 2023Actual

Completion Date

Jun 30, 2023Actual

First Submitted Date

Feb 12, 2020

First Submission Date that Met QC Criteria

Feb 13, 2020

First Posted Date

Feb 17, 2020Actual

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

Oct 21, 2023

Last Update Posted Date

Oct 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiong HU, Head, Blood & Marrow Transplantation Center, 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

For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be 5-day Fludarabine, 2-day Busulifan and 2-day melphalan

Detailed Description

For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be Fludarabine (30mg/m2, d-7 to d-3) + Busulifan 3.2mg/kg (d-7 to d-6) + melphalan 70mg/m2 (d-4 and d-3). The GVHD prophylaxis will be PT-CY (Cyclophosphamide 50mg/kg d+3 and d+4) + low-dose ATG (2.5mg/kg) on d+15.

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

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Flu-Bu-Mel	Experimental	Fludarabine 150mg/m2 + Busulfan 3.2mg/kg 2 days + melphalan 50-70mg/m2	Drug: Flu-Bu-Mel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flu-Bu-Mel	Drug	5-day fludarabine + 2-day busulfan (3.2mg/kg) + 2-day melphalan (50-70mg/m2)	Flu-Bu-Mel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease-free survival (DFS)	From transplantation to documentation of death or relapse or progression	1 year after transplantation

Secondary Outcomes

Measure	Description	Time Frame
Overall survival (OS)	From transplantation to documentation of death due to any causes	1 year after transplantation
Relapse rate	From transplantation to documentation of relapse or progression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute myeloid leukemia (CR1 or CR2) or myelodysplasia syndrome
patients with HLA matched sibling, unrelated or Haplo-identical donor

Exclusion Criteria:

patients with active infection
patients with abnormal liver function damage: ALT/AST above 2X normal range
patients with abnormal renal function damage Scr>160µmol/L;
patients with insufficient pulmonary function (FEV1，FVC，DLCO<50%）and heart failure or with EF <50%)
patients with mental instability or unwilling to give inform consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jion HU	Head BMT program, Rui Jin Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Blood & Marrow Transplantation Center, RuiJin Hospital		Shanghai		200025	China
Shanghai No6 Hospital

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