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
Acute Graft Versus Host DiseaseMalignant Hematologic Neoplasm
Investigational drug(s) / intervention(s)
Basiliximab
Basiliximab: Addition of CD25 monoclonal antibody（Basiliximab） at +3 days post unrelated umbilical cord blood transplantation (UCBT)
Study 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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD) — within 100 days post-UCBT 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.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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