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

Phase 4Not Yet RecruitingNCT06364319

Peking University People's Hospital30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

cGVHD

Interventions

anti-CD25 rhMAbDRUG

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.

PrednisoneDRUG

Maintain pre-screening dose

RuxolitinibDRUG

10mg, BID PO

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 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

Outcomes

Primary Outcomes

overall response rate (ORR)

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

Time frame: 56 days

Secondary Outcomes

duration of response（DOR）

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.

Time frame: 1 year

patient-reported outcomes (PRO)

the unabbreviated scale title is the Lee Chronic GVHD Symptom Scale.the minimum and maximum are 0 and 100, and higher scores mean a worse outcome.

Time frame: 1 year

disease-free survival (DFS)

DFS is defined as the duration of survival after treatment in which the original hematologic disease is in a state of complete remission.

Time frame: 1 year

failure-free survival (FFS)

Events that are considered as failures include the onset of new chronic GVHD, relapse, and death.

Time frame: 1 year

non-relapse mortality (NRM)

NRM is defined as death due to reasons other than progression/relapse of hematologic disease.

Time frame: 1 year

overall survival （OS）

OS is defined as the time from treatment until death from any cause or the last follow-up.

Time frame: 1 year

adverse drug reactions (ADR)

Data from ClinicalTrials.gov

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