NCT04203108

ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis

ATG Used in Allogeneic Hematopoietic Stem Cell Transplantation From HLA-matched Sibling Donor as GVHD Prophylaxis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematopoietic Stem Cell Transplantation

Interventions

Type	Name	Description
DRUG	ATG	In ATG group, ATG will be intravenously infused via a central venous catheter in day -1 at a dose of 2.5mg/kg.
DRUG	CsA	In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.
DRUG	MTX	In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).
DRUG	MMF	In both groups, MMF will be administrated at a dose of 1.0g/d.

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-08-31
• Completion: 2022-12-31
• First posted: 2019-12-18
• Last updated: 2019-12-18

Locations

1 site across 1 country: China