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

Launched by ANHUI PROVINCIAL HOSPITAL · Jun 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help prevent a serious condition called acute graft-versus-host disease (aGVHD) that can happen after receiving umbilical cord blood transplantation (UCBT) for blood cancers. Researchers are testing a medication made from a type of protein called a CD25 monoclonal antibody to see if it can safely reduce the chances of developing severe aGVHD in patients who have certain types of blood disorders.

To be eligible for this trial, patients must have a malignant hematologic disorder (like leukemia or lymphoma) and be planning to undergo UCBT. Female participants who can become pregnant need to have a negative pregnancy test and agree to use contraception during the study and for a year afterwards. Participants will be monitored closely to ensure their safety and to see how well the treatment works. It's important to know that this trial is not yet recruiting participants, so those interested will need to wait until it officially starts.

Gender

ALL

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).