Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD

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
Inclusion Criteria
  1. Age 16 and 65 years
  2. Received allogeneic hematopoietic stem cell transplantation
  3. Developed chronic GVHD in the liver after transplantation
  4. Ineffective prednisone treatment prior to screening
  5. Received ≤4 lines of systemic therapy prior to screening
  6. After informed consent, the patient agreed to receive anti-CD25 rhMAb treatment
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Exclusion Criteria
  1. Elevation of bilirubin, ALT, or alkaline phosphatase due to reasons other than chronic GVHD
  2. No prior treatment with prednisone
  3. Overlap syndrome
  4. Uncontrolled active infection
  5. Organ failure
  6. Early progression or recurrence of hematologic diseases
  7. Allergy to anti-CD25 rhMAb
  8. Received other interleukin-2 receptor monoclonal antibody treatment due to various reasons within one month after transplantation
  9. Participated in other clinical studies within one month
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Anti-CD25 rhMAb + traditional therapyPrednisone-
Anti-CD25 rhMAb + traditional therapyanti-CD25 rhMAb-
traditional therapyRuxolitinib-
Anti-CD25 rhMAb + traditional therapyRuxolitinib-
Anti-CD25 rhMAb + traditional therapyCyclosporine-
traditional therapyPrednisone-
traditional therapyCyclosporine-
Primary Outcome Measures
NameTimeMethod
overall response rate (ORR)56 days

ORR is defined as the percentage of complete response (CR) and partial response (PR).

Secondary Outcome Measures
NameTimeMethod
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.

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