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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
266
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).
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGthe incidence of cGVHD
cGVHD was graded as limited or extensive.
Time frame: 2 year posttransplantation
overall survival
Time frame: 2 year posttransplantation
disease-free survival
Time frame: 2 year posttransplantation
the incidence of aGVHD
aGVHD was defined according to the 1994 Consensus Conference on Acute GVHD Grading and graded from I to IV.
Time frame: 100 days 1 year posttransplantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
In both groups, MMF will be administrated at a dose of 1.0g/d.