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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-26

Study Completion Date

2026-03-26

Brief Summary

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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.

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Detailed Description

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Conditions

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GVHD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CD25 treatment

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

Group Type EXPERIMENTAL

CD25 treatment

Intervention Type DRUG

CD25 prophylaxis

low-dose ATG

Intervention Type DRUG

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

control group

Group Type OTHER

low-dose ATG

Intervention Type DRUG

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

Interventions

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CD25 treatment

CD25 prophylaxis

Intervention Type DRUG

low-dose ATG

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

Intervention Type DRUG

Eligibility Criteria

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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.).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No