About this trial
The first-line treatment of acute graft-versus-host disease with humanized CD25 monoclonal antibody combined with glucocorticoid was used to study the remission rate of acute graft-versus-host disease, the cumulative incidence and remission rate of severe acute graft-versus-host disease, GVHD-free survival rate, all-cause mortality and quality of life evaluation, and safety evaluation for prevention programs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
( 1 ) Diagnosis of grade II to IV acute graft-versus-host disease after hematopoietic stem cell transplantation.
Disqualifiers
• (1) diagnosed as VOD/SOS.
(2) Uncontrolled infection at enrollment; requires mechanical ventilation or is hemodynamically unstable at the time of enrollment;
(3) has severe hepatic insufficiency (defined as Child-Pugh Class C; has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 xthe upper limit of normal (ULN) or serum total bilirubin > 2.5 x ULN.
(4) has end-stage renal impairment with a creatinine clearance less than 10 mL/min.
Trial design
Single group
Treatments tested in this trial
CD25 antibody combined glucocorticoid as first-line treatment
DrugCD25 antibody combined glucocorticoid as first-line treatment
Treatment groups
Trial outcomes
Primary outcomes
The remission rate of aGVHD
Secondary outcomes
Incidence rate of severe aGVHD
overall survival
infection rate
relapse rate
Locations
Sponsors and contacts
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