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

NCT06480630 | Not Yet Recruiting Phase 2

• 1 other identifier: CD25-2024
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Graft Versus Host Disease; Malignant Hematologic Neoplasm

Outcome Measures

Primary Outcomes (1)

• The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD)

  The primary endpoint of the study will be the development of aGVHD in the first 100 days post-transplant. Acute GVHD was graded according to the International Consortium criteria.

  within 100 days post-UCBT

Secondary Outcomes (10)

• The incidence rate and occurrence time of pre-engraftment syndrome (PES)

  within 30 days post-UCBT

• The cumulative incidence of neutrophil engraftment at 28 days after transplantation

  within 28 days post-UCBT

• The cumulative incidence of platelet engraftment at 100 days after transplantation

  within 100 days post-UCBT

• The incidence of grade II to IV aGVHD

  within 100 days post-UCBT

• The cumulative incidence of chronic GVHD at 360 days after transplantation

  360 days

Study Arms (1)

basiliximab group

EXPERIMENTAL

Drug: Basiliximab

Interventions

Basiliximab DRUG

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

basiliximab group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

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

Hefei, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Basiliximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiaoyu Zhu, Ph.D

  The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyu Zhu, Ph.D

CONTACT

15255456091; xiaoyuz@ustc.edu.cn

Kaidi Song, M.D

CONTACT

18715062778; kaidisong@163.com

Study Design

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

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

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: June 28, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)