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

NCT ID: NCT06473909

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-31

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.

Conditions

Acute Graft Versus Host Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment arm

Group Type: EXPERIMENTAL

CD25 antibody combined glucocorticoid as first-line treatment

Intervention Type: DRUG

CD25 antibody combined glucocorticoid as first-line treatment

Interventions

CD25 antibody combined glucocorticoid as first-line treatment

CD25 antibody combined glucocorticoid as first-line treatment

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IIT2024017

Identifier Type: -

Identifier Source: org_study_id