Dose Study of Antithymocyteglobulin in Haploidentical Allogeneic Stem Cell Transplantation

Not Applicable

• Conditions: Hematopoietic Stem Cell Transplantation
• Interventions: Drug: ATG

• Registration Number: NCT02643589
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

The purpose of this study is to compare the incidences of GVHD in haploidentical hematopoietic stem cell transplant recipients receiving different dose of antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. The investigators' first objective was to investigate the optimal dose of ATG for aGVHD.

Detailed Description

Graft-versus-host diseases (GVHD) remains a major cause of morbility and mortality after allogeneic hematopoietic stem cell transplantation (HSCT) with grafts from an HLA-mismatched family donor. Antithymocyteglobulin (ATG) has been widely used to prevent acute GVHD (aGVHD) in haploidentical HSCT. Notwithstanding, immunosuppressive effect of ATG, which may also increase the risk of opportunistic infections, necessitates the use of the lowest possible dose. Till now, the optimal dose of ATG is not known. Here, the investigators compared the outcome of patients receiving haploidentical HSCT treated with two different doses of ATG.

Study Timeline

• Study Start: 2013-06
• Status Verified: 2015-12
• Study First Submitted: 2015-12-29
• Study First Submitted QC: 2015-12-30
• Last Update Submitted: 2015-12-30
• Study First Posted: 2015-12-31
• Last Update Posted: 2015-12-31
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Haploidentical hematopoietic stem cell transplant recipient
• Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria

• Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
• Patients with any conditions not suitable for the trial (investigators' decision)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATG 10mg/kg	ATG	ATG 10mg/kg group refers to treatment with ATG in the total dose of 10mg/kg.
ATG 7.5mg/kg	ATG	ATG 7.5mg/kg group refers to treatment with ATG in the total dose of 7.5mg/kg.

Primary Outcome Measures

Name	Time	Method
Incidence of acute GVHD	1 years	Acute GVHD was graded according to standard criteria.

Secondary Outcome Measures

Name	Time	Method
Immune reconstitution	3 years	Immune reconstitution is performed every 3 months after transplantation.
Survival	3 years	Survival includes overall and disease-free survival within 2 years after transplantation.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China