ATG-F VS ATG for the Prevention of GVHD | NCT03631563

Studies
ATG-F VS ATG for the Prevention of GVHD

NCT03631563

Sponsor

Fujian Medical University

Status

Unknown status

Last Update Posted

Aug 15, 2018Actual

Enrollment

120Estimated

Phase

Phase 2Phase 3

Conditions

GVHD in the Setting of Haplo-HSCT

Interventions

Immunosuppressive Agent

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

Aug 2018

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

Mar 1, 2013Actual

Primary Completion Date

Dec 1, 2018Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Aug 13, 2018

First Submission Date that Met QC Criteria

Aug 13, 2018

First Posted Date

Aug 15, 2018Actual

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

Aug 13, 2018

Last Update Posted Date

Aug 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Anti-thymocyte globulin (ATG) preparative regimen in the setting of haploidentical stem cell transplantation (haplo-HSCT) is vital for inducing immune tolerance.The study aims to compare the efficacy and safety of ATG-F vs ATG, incorporated into the preparative regimens for haplo-identical transplants.

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	ATG-F treated	Drug: Immunosuppressive Agent
Arm 2	Active Comparator	ATG treated	Drug: Immunosuppressive Agent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunosuppressive Agent	Drug	ATG-Fresenius versus ATG	Arm 1 Arm 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of GVHD		1 year

Secondary Outcomes

Measure	Description	Time Frame
leukemia-free survival		1 year
treatment-related mortality		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed written informed consent
Aged <65 years
Patients undergoing Haplo-identical hematopoietic stem cell transplantation.
Cardiac: Left ventricular ejection fraction ≥ 50%
Adequate renal and hepatic function
Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

Pregnant or lactating females.
Any co-morbidity precluding the administration of ATG or ATG-F.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ting Yang, Prof.M.D.Ph.D	Contact	86-13950210357		yang.hopeting@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Medical University Union Hospital	Recruiting	Fuzhou	Fujian	350001	China

Intervention Browse Module

MeSH Terms

ID	Term
D007166	Immunosuppressive Agents

Ancestor Terms

ID	Term
D007155	Immunologic Factors
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

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Browse Branches

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