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

The Study of Anti-CD25 Antibody for Prophylaxis of GVHD in Patients Underwent Haploid Transplantation Conditioning With Low-dose ATG

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.

Study Overview

• Status: Not yet recruiting
• Conditions: GVHD
• Intervention / Treatment: Drug: CD25 treatment; Drug: low-dose ATG

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaosheng Fang; Phone Number: 8615168889703 8615168889703; Email: fxsh_1010@126.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250021
      • Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University
      • Contact: Xin Wang, MD, PHD; Phone Number: 86-531-68778331; Email: xinw007@126.com
      • Contact: Xiaosheng Fang, MD, PHD; Phone Number: 8615168889703; Email: fxsh_1010@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• Those deemed unsuitable for inclusion by the researcher (such as patients expected to be unable to adhere to treatment due to financial issues, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group	Drug: low-dose ATG; HSCT pre-treatment with 7.5mg/Kg ATG(2.5mg/Kg/d) at day -4, -3 and -2.
Experimental: CD25 treatment; The humanized CD25 antibody was administered at 1 mg/kg iv on days+4 and +7 after HSCT.	Drug: CD25 treatment; CD25 prophylaxis; Drug: low-dose ATG; HSCT pre-treatment with 7.5mg/Kg ATG(2.5mg/Kg/d) at day -4, -3 and -2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time of immune reconstitution in haploidentical transplant	the time of immune reconstitution in haploidentical transplant	2 years after HSCT
the time of infection occurrence	The incidence of infection	2 years after HSCT
the time of donor cell engraftment	the effect of experimental protocol to engraftment	2 years after HSCT
the time of disease relapse	the effect of experimental protocol to disease relapse	2 years after HSCT
the time of death of transplant patient	the overall survival of patients	2 years after HSCT

Collaborators and Investigators

• Sponsor: Wang Xin
• Investigators: Study Chair: Xin Wang, Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 26, 2024
• Primary Completion (Estimated): March 26, 2026
• Study Completion (Estimated): March 26, 2026

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SWYX:NO.2022-1028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We need to collect data during the experiment for a more comprehensive sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No