Flu-Bu-Mel Based Conditioning Regimen for Patients With L... | NCT04897139

Studies
Flu-Bu-Mel Based Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allo-HSCT

NCT04897139

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Oct 25, 2023Actual

Enrollment

23Estimated

Phase

Phase 2

Conditions

Lymphoid Neoplasm

Interventions

Flu-Bu-Mel-E

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

May 19, 2021

First Submission Date that Met QC Criteria

May 20, 2021

First Posted Date

May 21, 2021Actual

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, BMT program, 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 phase II clinical trial, we evaluate the efficacy and feasibility of conditioning regimen of fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2 in patients with lymphoid malignancies.

Detailed Description

Not provided

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

23Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment arm	Experimental	treatment arm	Drug: Flu-Bu-Mel-E

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flu-Bu-Mel-E	Drug	Fludarabine 150mg/m2, busulfan 6.4mg/kg, melphalan 100mg/m2 and etoposide 600mg/m2	treatment arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease-free survival	event defined as disease progression, relapse or death of any causes	1 year after allo-HSCT

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	event defined as death of any causes	1 year after allo-HSCT
Non relapse morality	event defined as death of any causes except for disease progression or relapse

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

lymphoid malignancies
donor available: HLA matched sibling, unrelated donor or haplo-identical related donor.
patients with ECOG <3

Exclusion Criteria:

inform consent not provided
ECOG >=3
poor liver function (enzyme >2N or bilirubin >2N)
poor renal function (Scr >2N)
poor cardiac function (EF <45%)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiong Hu	Contact	86-21-64370045	601818	hj10709@rjh.com.cn
Jieling Jiang	Contact	86-21-64370045	601818	jjl12223@rjh.com.cn

Overall Officials

Name	Affiliation	Role
Jiong HU	Ruijin Hospital	Principal Investigator

Locations

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