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Trial 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
NCT ID:
NCT06480630
Condition:
Acute Graft Versus Host Disease
Malignant Hematologic Neoplasm
Conditions: Official terms:
Hematologic Neoplasms
Hematologic Diseases
Graft vs Host Disease
Basiliximab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Addition of CD25 monoclonal antibody at +3 days post unrelated umbilical cord blood
transplantation (UCBT)
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Basiliximab
Description:
Addition of CD25 monoclonal antibody（Basiliximab） at +3 days post unrelated umbilical
cord blood transplantation (UCBT)
Arm group label:
basiliximab group
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.
Criteria for 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).
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Address:
City:
Hefei
Country:
China
Contact:
Last name:
Xiaoyu Zhu, Ph.D
Phone:
15255456091
Email:
xiaoyuz@ustc.cn
Contact backup:
Last name:
Kaidi Song, M.D
Phone:
18715062778
Email:
kaidisong@163.com
Start date:
July 1, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06480630
