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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • anti-CD25 rhMAb

    Drug

    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.

  • Prednisone

    Drug

    Maintain pre-screening dose

  • Ruxolitinib

    Drug

    10mg, BID PO

  • Cyclosporine

    Drug

    1.25mg/kg, BID PO/IV, target:150-250ng/ml

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Anti-CD25 rhMAb + traditional therapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

overall response rate (ORR)

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

Time frame
56 days

Secondary outcomes

1

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
2

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
3

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
4

failure-free survival (FFS)

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

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: