ATG-F VS ATG for the Prevention of GVHD

Phase 2

• Conditions: GVHD in the Setting of Haplo-HSCT
• Interventions: Drug: Immunosuppressive Agent

• Registration Number: NCT03631563
• Lead Sponsor: Fujian Medical University

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 available

Study Timeline

• Study Start: 2013-03-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15
• Primary Completion: 2018-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Immunosuppressive Agent	ATG-F treated
Arm 2	Immunosuppressive Agent	ATG treated

Primary Outcome Measures

Name	Time	Method
incidence of GVHD	1 year

Secondary Outcome Measures

Name	Time	Method
leukemia-free survival	1 year
treatment-related mortality	1 year

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China