Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD
ConditioncGVHD
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16-65
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Elevation of bilirubin, ALT, or alkaline phosphatase due to reasons other than chronic GVHD
No prior treatment with prednisone
Overlap syndrome
Uncontrolled active infection
Trial design
Treatments tested in this trial
- anti-CD25 rhMAb
- Prednisone
- Ruxolitinib
- Cyclosporine
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov