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

University of Science and Technology of China (USTC)

Status and phase

Not yet enrolling

Phase 2

Conditions

Malignant Hematologic Neoplasm

Acute Graft Versus Host Disease

Treatments

Drug: Basiliximab

Study type

Interventional

Funder types

Other

Identifiers

NCT06480630

CD25-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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).