Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model

Phase 2RecruitingNCT06880419

Institute of Hematology & Blood Diseases Hospital, China174 enrolled

Overview

To assess the efficacy and safety of using recombinant humanized anti-CD25 monoclonal antibody injection as a prophylactic strategy for reducing the incidence of severe acute graft-versus-host disease (aGVHD) in adult patients at intermediate to high risk, as predicted by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model, following allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

174

Conditions

Acute Graft-versus-Host Disease

Interventions

Recombinant Humanized Anti-CD25 Monoclonal Antibody InjectionDRUG

Model-predicted patients at high risk (HR): Recombinant humanized anti-CD25 monoclonal antibody: 50 mg/day when the post-transplant model predicts high risk in the second week post-prediction and 25 mg/day in the fourth and sixth weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at moderate risk (MR): Recombinant anti-CD25 humanized monoclonal antibody: 25 mg/day when the model predicts intermediate risk post-transplantation and at the 2nd, 4th, and 6th weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at low-risk (LR): A conventional aGVHD prevention regimen only was used.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 16 years, regardless of gender. 2. Patients with hematologic disorders who are scheduled to receive allo-HSCT. 3. Voluntarily join this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up. Exclusion Criteria: 1. Patients who have received a second or multiple transplants. 2. Patients who are allergic to, or intolerant of, a recombinant humanized anti-CD25 monoclonal antibody injection. 3. Pregnant or lactating female patients or female patients who are unable to take effective contraceptive measures during the entire trial period.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation

Time frame: 100 days after transplantation