Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD
- Conditions
- Interventions
- Registration Number
- NCT06364319
- Lead Sponsor
- Peking University People's Hospital
- 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 be randomly assigned to either the Anti-CD25 rhMAb treatment group or the traditional treatment group. The objective is to assess th...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 118
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anti-CD25 rhMAb + traditional therapy Prednisone - Anti-CD25 rhMAb + traditional therapy anti-CD25 rhMAb - traditional therapy Ruxolitinib - Anti-CD25 rhMAb + traditional therapy Ruxolitinib - Anti-CD25 rhMAb + traditional therapy Cyclosporine - traditional therapy Prednisone - traditional therapy Cyclosporine -
- Primary Outcome Measures
Name Time Method overall response rate (ORR) 56 days ORR is defined as the percentage of complete response (CR) and partial response (PR).
- Secondary Outcome Measures
Name Time Method patient-reported outcomes (PRO) 1 year Based on the Lee Chronic GVHD Symptom Scale.
failure-free survival (FFS) 1 year Events that are considered as failures include the onset of new chronic GVHD, relapse, and death.
non-relapse mortality (NRM) 1 year NRM is defined as death due to reasons other than progression/relapse of hematologic disease.
overall survival (OS) 1 year OS is defined as the time from treatment until death from any cause or the last follow-up.
adverse drug reactions (ADR) 1 year The occurrence of various organ toxicities related to treatment that emerge following treatment.
duration of response(DOR) 1 year DOR is defined as the duration calculated from the time of achieving PR or CR until the progression of GVHD, the addition of other systemic immunosuppressive therapy, or death.
disease-free survival (DFS) 1 year DFS is defined as the duration of survival after treatment in which the original hematologic disease is in a state of complete remission.