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Recruiting NCT06880419

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

Phase II Interventional Acute Graft-versus-Host Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection.
Who it may be relevant to
Registry conditions: Acute Graft-versus-Host Disease. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Prospective, Single-arm, Historically Controlled, Single-center Study for Preventing aGVHD, Post-allogeneic HSCT, in Adults at Moderate-to-high Risk Using Recombinant Humanized Anti-CD25 Monoclonal Antibody Based on the daGOAT Model

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).

Interventions

  • Drug Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection
    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

Primary outcome measures

  • Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation [Time frame: 100 days after transplantation]
Secondary outcome measures (11)
  • Incidence of aGVHD and aGVHD (any grade) in each target organ within 100 days post-transplantation [Time frame: 100 days after transplantation]
  • Engraftment rate [Time frame: 180 days after transplantation]
  • Disease relapse rate [Time frame: 180 days after transplantation]
  • Infection rate [Time frame: 180 days after transplantation]
  • Overall survival [Time frame: 180 days after transplantation]
  • Non-relapse mortality [Time frame: 180 days after transplantation]
  • GVHD-free relapse-free survival [Time frame: 180 days after transplantation]
  • Overall Response Rate of severe aGVHD treatment [Time frame: 100 days after transplantation]
  • Incidence of chronic GVHD [Time frame: 180 days after transplantation]
  • Adverse events [Time frame: 180 days after transplantation]
  • Total cost of treatment [Time frame: 180 days after transplantation]

Eligibility criteria

Inclusion criteria

  • Age ≥ 16 years, regardless of gender.
  • Patients with hematologic disorders who are scheduled to receive allo-HSCT.
  • Voluntarily join this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.

Exclusion criteria

  • Patients who have received a second or multiple transplants.
  • Patients who are allergic to, or intolerant of, a recombinant humanized anti-CD25 monoclonal antibody injection.
  • Pregnant or lactating female patients or female patients who are unable to take effective contraceptive measures during the entire trial period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Institute of Hematology & Blood Diseases Hospital — Tianjin

Identifiers

NCT: NCT06880419 · IIT2024115

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗