Acute Graft Versus Host Disease
Conditions
Keywords
aGVHD, humanized CD25 monoclonal antibody, glucocorticoid
Brief summary
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.
Interventions
DRUGCD25 antibody combined glucocorticoid as first-line treatment
CD25 antibody combined glucocorticoid as first-line treatment
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ( 1 ) Diagnosis of grade II to IV acute graft-versus-host disease after hematopoietic stem cell transplantation. ( 2 ) older than or equal to 18 years old. ( 3 ) Informed consent can be signed by themselves. ( 4 ) HIV negative, HBV, HCV negative. ( 5 ) Informed consent must be signed before the start of the study procedure. The informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent will be signed by the legal guardian or the patient 's immediate family.
Exclusion criteria
* • (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. * (5) has both moderate hepatic insufficiency AND moderate renal insufficiency; * (6) has documented positive results for human immunodeficiency virus antibody (HIVAb), hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollments; * (7) has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas). * (8) Suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring; * (9) unable or unwilling to sign the consent form; * (10) patients with other special conditions assessed as unqualified by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The remission rate of aGVHD | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of severe aGVHD | 24 weeks |
| overall survival | 24 weeks |
| infection rate | 24 weeks |
| relapse rate | 24 weeks |
| non-relapse mortality | 24 weeks |
Outcome results
None listed