Study on the Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease (cGVHD) of the Liver Following Allogeneic Hematopoietic Stem Cell Transplantation.
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 30
- Primary Endpoint
- overall response rate (ORR)
Study Overview
Brief Summary
The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will receive a treatment regimen consisting of the Anti-CD25 rhMAb in combination with prednisone, cyclosporine, and ruxolitinib.The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None (Participant, Investigator)
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 16 and 65 years
- •Received allogeneic hematopoietic stem cell transplantation
- •Developed chronic GVHD in the liver after transplantation
- •Ineffective prednisone treatment prior to screening
- •Received ≤4 lines of systemic therapy prior to screening
- •After informed consent, the patient agreed to receive anti-CD25 rhMAb treatment
Exclusion Criteria
- •Elevation of bilirubin, ALT, or alkaline phosphatase due to reasons other than chronic GVHD
- •No prior treatment with prednisone
- •Overlap syndrome
- •Uncontrolled active infection
- •Organ failure
- •Early progression or recurrence of hematologic diseases
- •Allergy to anti-CD25 rhMAb
- •Received other interleukin-2 receptor monoclonal antibody treatment due to various reasons within one month after transplantation
- •Participated in other clinical studies within one month
Arms & Interventions
Anti-CD25 rhMAb + traditional therapy
Intervention: Ruxolitinib (Drug)
Anti-CD25 rhMAb + traditional therapy
Intervention: Cyclosporine (Drug)
Anti-CD25 rhMAb + traditional therapy
Intervention: anti-CD25 rhMAb (Drug)
Anti-CD25 rhMAb + traditional therapy
Intervention: Prednisone (Drug)
Outcomes
Primary Outcomes
overall response rate (ORR)
Time Frame: 56 days
ORR is defined as the percentage of complete response (CR) and partial response (PR).
Secondary Outcomes
- duration of response（DOR）(1 year)
- disease-free survival (DFS)(1 year)
- failure-free survival (FFS)(1 year)
- non-relapse mortality (NRM)(1 year)
- overall survival （OS）(1 year)
- adverse drug reactions (ADR)(1 year)
- patient-reported outcomes (PRO)(1 year)
Investigators
Xiao-Jun Huang
Director
Peking University People's Hospital