Combination of Steroid and Humanized CD25 Monoclonal Antibody as First-line Therapy for aGVHD

Institute of Hematology & Blood Diseases Hospital, China

Status and phase

Not yet enrolling

Phase 2

Conditions

Acute Graft Versus Host Disease

Treatments

Drug: CD25 antibody combined glucocorticoid as first-line treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06473909

IIT2024017

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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