Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT

NCT06334367 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SWYX:NO.2022-1028
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. In order to explore better methods for controlling GVHD, we designed a clinical trial using CD25 monoclonal antibody for GVHD prevention. Our previous studies have shown that reduced-dose anti-thymocyte globulin(ATG) in the conditioning regimen can achieve the same effect as full-dose ATG. Here, we try to explore the preventive effect of CD25 antibody on acute and chronic GHVD under low-dose ATG pretreatment condition.

Conditions

GVHD

Outcome Measures

Primary Outcomes (2)

• The incidence of aGVHD

  The time of aGVHD occurrence

  100 days after HSCT

• The incidence of cGVHD

  The time of cGVHD occurrence

  1 year after HSCT

Secondary Outcomes (5)

• the time of immune reconstitution in haploidentical transplant

  2 years after HSCT

• the time of infection occurrence

  2 years after HSCT

• the time of donor cell engraftment

  2 years after HSCT

• the time of disease relapse

  2 years after HSCT

• the time of death of transplant patient

  2 years after HSCT

Study Arms (2)

CD25 treatment

EXPERIMENTAL

The humanized CD25 antibody was administered at 1 mg/kg iv on days+4 and +7 after HSCT.

Drug: CD25 treatment; Drug: low-dose ATG

control group

OTHER

Drug: low-dose ATG

Interventions

CD25 treatment DRUG

CD25 prophylaxis

CD25 treatment

low-dose ATG DRUG

HSCT pre-treatment with 7.5mg/Kg ATG(2.5mg/Kg/d) at day -4, -3 and -2.

CD25 treatment; control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a clear diagnosis of hematologic disease, weighing ≥30kg, aged 18-60, of any gender and race;
• Willing to undergo haploidentical hematopoietic stem cell transplantation;
• Voluntarily participate in this study;
• Each subject must sign an informed consent form (ICF) indicating their understanding of the purpose and procedures of the study, and their willingness to participate. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member.

You may not qualify if:

• Those with severe organ dysfunction or diseases, such as heart, liver, kidney, and pancreatic diseases;
• Patients who cannot tolerate CD25 monoclonal antibody treatment;
• Subjects and/or authorized family members who refuse allo-HSCT treatment;
• Any life-threatening diseases, physical conditions, or organ system dysfunctions that the researcher believes may jeopardize the safety of the subject and pose unnecessary risks to the study; drug dependence; uncontrolled mental illness in subjects; cognitive dysfunction;
• Those who have participated in other similar clinical studies within the past 3 months;

Sponsors & Collaborators

• Wang Xin: lead

Study Sites (1)

Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250021, China

Location

Study Officials

• Xin Wang

  Shandong Provincial Hospital

  STUDY CHAIR

Central Study Contacts

Xiaosheng Fang

CONTACT

8615168889703; fxsh_1010@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department of Hematology

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 28, 2024
• Study Start: March 26, 2024
• Primary Completion: March 26, 2026
• Study Completion: March 26, 2026
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)