Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD
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: anti-CD25 rhMAb, Prednisone, Ruxolitinib, Cyclosporine.
- Who it may be relevant to
- Registry conditions: cGVHD. Basic parameters: 16 years — 65 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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.
Interventions
- Drug anti-CD25 rhMAb
1 mg/kg/day administered IV day 1, 4, and 8, then weekly for 6 doses. For patients achieving partial remission, an extra dose of Anti-CD25 rhMAb can be given on days 39 and 49. - Drug Prednisone
Maintain pre-screening dose - Drug Ruxolitinib
10mg, BID PO - Drug Cyclosporine
1.25mg/kg, BID PO/IV, target:150-250ng/ml
Primary outcome measures
- overall response rate (ORR) [Time frame: 56 days]
Secondary outcome measures (10)
- duration of response（DOR） [Time frame: 1 year]
- patient-reported outcomes (PRO) [Time frame: 1 year]
- disease-free survival (DFS) [Time frame: 1 year]
- failure-free survival (FFS) [Time frame: 1 year]
- non-relapse mortality (NRM) [Time frame: 1 year]
- overall survival （OS） [Time frame: 1 year]
- adverse drug reactions (ADR) [Time frame: 1 year]
- Best Overall Response Rate (ORR) of Overall cGVHD [Time frame: 1 year]
- Immune Reconstitution [Time frame: 1 year]
- Quality of Life Assessment [Time frame: 1 year]
Eligibility criteria
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
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
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06364319 · 2024PHD002-001