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

Phase 2

Not yet recruiting

• Conditions: Acute Graft Versus Host Disease
• Interventions: Drug: CD25 antibody combined glucocorticoid as first-line treatment

• Registration Number: NCT06473909
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Study Start: 2024-07-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	CD25 antibody combined glucocorticoid as first-line treatment	-

Primary Outcome Measures

Name	Time	Method
The remission rate of aGVHD	28 days

Secondary Outcome Measures

Name	Time	Method
Incidence rate of severe aGVHD	24 weeks
infection rate	24 weeks
relapse rate	24 weeks
non-relapse mortality	24 weeks
overall survival	24 weeks