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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Graft Versus Host Disease; Malignant Hematologic Neoplasm
• Intervention / Treatment: Drug: Basiliximab

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.

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoyu Zhu, Ph.D; Phone Number: 15255456091; Email: xiaoyuz@ustc.edu.cn
• Study Contact Backup: Name: Kaidi Song, M.D; Phone Number: 18715062778; Email: kaidisong@163.com

Study Locations

• China
  • Hefei, China
    • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
    • Contact: Xiaoyu Zhu, ph.D; Phone Number: 15255456091; Email: xiaoyuz@ustc.cn
    • Contact: Kaidi Song, M.D; Phone Number: 18715062778; Email: kaidisong@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: basiliximab group	Drug: Basiliximab; Addition of CD25 monoclonal antibody（Basiliximab） at +3 days post unrelated umbilical cord blood transplantation (UCBT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD)	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.	within 100 days post-UCBT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cumulative incidence of transplant-related mortality at 180 days after transplantation	The cumulative incidence of transplant-related mortality at 180 days after transplantation.	180 days
The cumulative incidence of chronic GVHD at 360 days after transplantation	The severity of chronic GVHD was graded according to the 2014 NIH criteria.	360 days
The incidence rate and occurrence time of pre-engraftment syndrome (PES)	The occurrence time and cumulative incidence of PES within 30 days post-UCBT. The PES was diagnosed according to the criteria of engraftment syndrome (ES) .	within 30 days post-UCBT
The cumulative incidence of neutrophil engraftment at 28 days after transplantation	Neutrophil engraftment time was defined as the first of three consecutive days during which the neutrophil count was at least 0.5×10^9/L.	within 28 days post-UCBT
The cumulative incidence of platelet engraftment at 100 days after transplantation	Platelet engraftment is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥ 20 × 10^9/L.	within 100 days post-UCBT
The incidence of grade II to IV aGVHD	The cumulative incidence of grade II to IV aGVHD in the first 100 days post-transplant. aGVHD was graded according to the aGVHD International Consortium criteria.	within 100 days post-UCBT
The cumulative incidence of relapse	The cumulative incidence of relapse at 1 year after transplantation.	1 year
The probability of disease-free survival(DFS)	The DFS was defined as the interval between transplantation and disease recurrence, death or the last follow-up date, whichever occurred first.	1 year
The probability of overall survival(OS)	The OS was determined to be the time from the first day of transplantation until death from any cause or the last follow-up date.	1 year
The probability of GVHD-free, relapse-free survival(GRFS)	The composite endpoint of GRFS was defined as the first events occurring after transplantation among Grade III to IV aGVHD, moderate to severe cGVHD, relapse, or death for any reason.	1 year

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Principal Investigator: Xiaoyu Zhu, ph.D, The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms; Neoplasms by Site; Hematologic Neoplasms; Hematologic Diseases; Graft vs Host Disease; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Basiliximab
• Other Study ID Numbers: CD25-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No