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

Phase 2

Not yet recruiting

• Conditions: Acute Graft Versus Host Disease; Malignant Hematologic Neoplasm
• Interventions: Drug: Basiliximab

• Registration Number: NCT06480630
• Lead Sponsor: Anhui Provincial Hospital

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study First Posted: 2024-06-28
• Last Update Posted: 2024-06-28
• Study Start: 2024-07-01
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
basiliximab group	Basiliximab	-

Primary Outcome Measures

Name	Time	Method
The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD)	within 100 days post-UCBT	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.

Secondary Outcome Measures

Name	Time	Method
The incidence rate and occurrence time of pre-engraftment syndrome (PES)	within 30 days post-UCBT	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) .
The cumulative incidence of neutrophil engraftment at 28 days after transplantation	within 28 days post-UCBT	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.
The cumulative incidence of platelet engraftment at 100 days after transplantation	within 100 days post-UCBT	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.
The incidence of grade II to IV aGVHD	within 100 days post-UCBT	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.
The cumulative incidence of chronic GVHD at 360 days after transplantation	360 days	The severity of chronic GVHD was graded according to the 2014 NIH criteria.
The cumulative incidence of transplant-related mortality at 180 days after transplantation	180 days	The cumulative incidence of transplant-related mortality at 180 days after transplantation.
The cumulative incidence of relapse	1 year	The cumulative incidence of relapse at 1 year after transplantation.
The probability of disease-free survival(DFS)	1 year	The DFS was defined as the interval between transplantation and disease recurrence, death or the last follow-up date, whichever occurred first.
The probability of overall survival(OS)	1 year	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.
The probability of GVHD-free, relapse-free survival(GRFS)	1 year	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital); 🇨🇳 Hefei, China