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Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases

NCT ID: NCT06480630

Last Updated: 2024-06-28

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2027-06-30

Brief Summary

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Evaluating the safety and effectiveness of a CD25 monoclonal antibody-based prophylactic acute graft-versus-host-disease (aGVHD) regimen following unrelated umbilical cord blood transplantation (UCBT) for malignant hematologic disorders in reducing severe aGVHD.

Detailed Description

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Acute graft-versus-host disease (aGVHD) is a major complication and leading cause of non-relapse mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Preliminary research findings suggest that the addition of CD25 monoclonal antibody at +3 days post unrelated umbilical cord blood transplantation (UCBT) has reduced the incidence of grade III-IV aGVHD compared to previous protocols. In order to further explore how to improve prevention strategies of aGVHD and reduce the incidence of severe aGVHD, we performed this study to evaluate the safety and effectiveness of a prophylactic GVHD regimen utilizing CD25 monoclonal antibody post-UCBT for malignant hematologic disorders, aimed at reducing the incidence of severe aGVHD.

Conditions

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Acute Graft Versus Host Disease Malignant Hematologic Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Addition of CD25 monoclonal antibody at +3 days post unrelated umbilical cord blood transplantation (UCBT)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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basiliximab group

Group Type EXPERIMENTAL

Basiliximab

Intervention Type DRUG

Addition of CD25 monoclonal antibody（Basiliximab） at +3 days post unrelated umbilical cord blood transplantation (UCBT)

Interventions

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Basiliximab

Addition of CD25 monoclonal antibody（Basiliximab） at +3 days post unrelated umbilical cord blood transplantation (UCBT)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Malignant hematologic disorders;
* Patients undergoing UCBT;
* Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during treatment and for the following year.

Exclusion Criteria

* Non-malignant hematologic disorders;
* History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
* Uncontrolled bacterial, viral, or fungal infections. "Uncontrolled" is defined as lack of clinical improvement or progression despite adequate antimicrobial therapy;
* HIV infection or active hepatitis B or C virus infection;
* Pregnant or lactating women;
* Substance abusers; subjects with uncontrolled psychiatric disorders; individuals with cognitive dysfunction;
* Participation in similar clinical studies within the past 3 months;
* Subjects deemed unsuitable by the investigator (e.g., those expected to be unable to adhere to treatment due to financial constraints).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaoyu Zhu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Locations

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The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, , China

Site Status

Countries

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China

Central Contacts

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Xiaoyu Zhu, Ph.D

Role: CONTACT

Phone: 15255456091

Email: [email protected]

Kaidi Song, M.D

Role: CONTACT

Phone: 18715062778

Email: [email protected]

Facility Contacts

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Xiaoyu Zhu, Ph.D

Role: primary

Kaidi Song, M.D

Role: backup

Other Identifiers

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CD25-2024

Identifier Type: -

Identifier Source: org_study_id