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

NCT06473909 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT2024017
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

aGVHD; humanized CD25 monoclonal antibody; glucocorticoid

Outcome Measures

Primary Outcomes (1)

• The remission rate of aGVHD

  28 days

Secondary Outcomes (5)

• Incidence rate of severe aGVHD

  24 weeks

• overall survival

  24 weeks

• infection rate

  24 weeks

• relapse rate

  24 weeks

• non-relapse mortality

  24 weeks

Study Arms (1)

treatment arm

EXPERIMENTAL

Drug: CD25 antibody combined glucocorticoid as first-line treatment

Interventions

CD25 antibody combined glucocorticoid as first-line treatment DRUG

CD25 antibody combined glucocorticoid as first-line treatment

treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ( 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.

You may not qualify if:

• (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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share