At a glance
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ATG Used in Allogeneic Hematopoietic Stem Cell Transplantation From HLA-matched Sibling Donor as GVHD Prophylaxis
In Brief
A Phase 4 clinical trial evaluating ATG, CsA, and 2 other interventions for Hematopoietic Stem Cell Transplantation. Targeting 266 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
In ATG group, ATG will be intravenously infused via a central venous catheter in day -1 at a dose of 2.5mg/kg.
In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.
In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).
In both groups, MMF will be administrated at a dose of 1.0g/d.