ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis

Phase 4

• Conditions: Hematopoietic Stem Cell Transplantation
• Interventions: Drug: ATG; Drug: CsA; Drug: MTX; Drug: MMF

• Registration Number: NCT04203108
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

The protocols including ciclosporin A （CsA）+methotrexate (MTX) +mycophenolate Mofetil(MMF) have been widely used for graft-versus-host disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from HLA-matched sibling donor (MSD). Nevertheless, severe chronic graft-versus-host disease (cGVHD) remains an obstacle for MSD HSCT. A growing body of studies have suggested antithymocyte globulin (ATG) could reduce the incidence of cGVHD. This study is aim to evaluate the efficacy of a protocol that includes CsA, MTX, MMF and ATG in recipients of MSD HSCT.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Last Update Submitted: 2019-12-16
• Study First Posted: 2019-12-18
• Last Update Posted: 2019-12-18
• Primary Completion: 2021-08-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

1. A patient age of 18-65 years
2. MSD transplant recipient
3. 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

1. Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
2. 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 group	MTX	ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis.
ATG group	ATG	ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis.
ATG group	MMF	ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis.
ATG group	CsA	ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis.
non-ATG group	MTX	Non-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis.
non-ATG group	CsA	Non-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis.
non-ATG group	MMF	Non-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis.

Primary Outcome Measures

Name	Time	Method
the incidence of cGVHD	2 year posttransplantation	cGVHD was graded as limited or extensive.

Secondary Outcome Measures

Name	Time	Method
disease-free survival	2 year posttransplantation
the incidence of aGVHD	100 days 1 year posttransplantation	aGVHD was defined according to the 1994 Consensus Conference on Acute GVHD Grading and graded from I to IV.
overall survival	2 year posttransplantation

Trial Locations

Locations (1)

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