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Not yet recruiting NCT06480630

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

Phase II Interventional Acute Graft Versus Host Disease Malignant Hematologic Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Basiliximab.
Who it may be relevant to
Registry conditions: Acute Graft Versus Host Disease, Malignant Hematologic Neoplasm. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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.

Interventions

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

Primary outcome measures

  • The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD) [Time frame: within 100 days post-UCBT]
Secondary outcome measures (10)
  • The incidence rate and occurrence time of pre-engraftment syndrome (PES) [Time frame: within 30 days post-UCBT]
  • The cumulative incidence of neutrophil engraftment at 28 days after transplantation [Time frame: within 28 days post-UCBT]
  • The cumulative incidence of platelet engraftment at 100 days after transplantation [Time frame: within 100 days post-UCBT]
  • The incidence of grade II to IV aGVHD [Time frame: within 100 days post-UCBT]
  • The cumulative incidence of chronic GVHD at 360 days after transplantation [Time frame: 360 days]
  • The cumulative incidence of transplant-related mortality at 180 days after transplantation [Time frame: 180 days]
  • The cumulative incidence of relapse [Time frame: 1 year]
  • The probability of disease-free survival(DFS) [Time frame: 1 year]
  • The probability of overall survival(OS) [Time frame: 1 year]
  • The probability of GVHD-free, relapse-free survival(GRFS) [Time frame: 1 year]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • The First Affiliated Hospital of University of Science and Technology of China (Anhui Prov — Hefei

Identifiers

NCT: NCT06480630 · CD25-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗