Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Acute Graft Versus Host Disease
Malignant Hematologic Neoplasm
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-28
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Addition of CD25 monoclonal antibody at +3 days post unrelated umbilical cord blood transplantation (UCBT)
Primary purpose: PREVENTION

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.

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.

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).

Primary outcomes:
measure: The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD)
timeFrame: within 100 days post-UCBT
Secondary outcomes:
measure: The incidence rate and occurrence time of pre-engraftment syndrome (PES)
timeFrame: within 30 days post-UCBT
measure: The cumulative incidence of neutrophil engraftment at 28 days after transplantation
timeFrame: within 28 days post-UCBT
measure: The cumulative incidence of platelet engraftment at 100 days after transplantation
timeFrame: within 100 days post-UCBT
measure: The incidence of grade II to IV aGVHD
timeFrame: within 100 days post-UCBT
measure: The cumulative incidence of chronic GVHD at 360 days after transplantation
timeFrame: 360 days
measure: The cumulative incidence of transplant-related mortality at 180 days after transplantation
timeFrame: 180 days
measure: The cumulative incidence of relapse
timeFrame: 1 year
measure: The probability of disease-free survival(DFS)
timeFrame: 1 year
measure: The probability of overall survival(OS)
timeFrame: 1 year
measure: The probability of GVHD-free, relapse-free survival(GRFS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Study officials:
affiliation: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
name: Xiaoyu Zhu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: