ATG-F VS ATG for the Prevention of GVHD

Sponsor

Fujian Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03631563

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
GVHD in the Setting of Haplo-HSCT	Drug: Immunosuppressive Agent	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparing ATG-Fresenius vs Thymoglobulin for the Prevention of Graft-versus-host Disease in the Setting of Haplo-identical Hematopoietic Stem Cell Transplantation

Actual Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 ATG-F treated	Drug: Immunosuppressive Agent ATG-Fresenius versus ATG
Active Comparator: Arm 2 ATG treated	Drug: Immunosuppressive Agent ATG-Fresenius versus ATG

Arm

Intervention/Treatment

Experimental: Arm 1

ATG-F treated

Drug: Immunosuppressive Agent

ATG-Fresenius versus ATG

Active Comparator: Arm 2

ATG treated

Drug: Immunosuppressive Agent

ATG-Fresenius versus ATG

Outcome Measures

Primary Outcome Measures

incidence of GVHD [1 year]

Secondary Outcome Measures

leukemia-free survival [1 year]
treatment-related mortality [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fujian Medical University Union Hospital	Fuzhou	Fujian	China	350001

Sponsors and Collaborators

Fujian Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ting YANG, Prof.M.D.Ph.D, Fujian Medical University

ClinicalTrials.gov Identifier:

NCT03631563

Other Study ID Numbers:

ATG-F VS ATG-01

First Posted:

Aug 15, 2018

Last Update Posted:

Aug 15, 2018

Last Verified:

Aug 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Immunosuppressive Agents

Study Results

No Results Posted as of Aug 15, 2018