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

Peking University

Status and phase: Not yet enrolling; Phase 4

Conditions: cGVHD

Treatments: Drug: Ruxolitinib; Drug: anti-CD25 rhMAb; Drug: Prednisone; Drug: Cyclosporine

Study type: Interventional

Funder types: Other

Identifiers

NCT06364319

2024PHD002-001

Details and patient eligibility

About

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 the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver.

Enrollment: 118 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

118 participants in 2 patient groups, including a placebo group

Anti-CD25 rhMAb + traditional therapy

Experimental group

Treatment:

Drug: Prednisone

Drug: Cyclosporine

Drug: anti-CD25 rhMAb

Drug: Ruxolitinib

traditional therapy

Placebo Comparator group

Treatment:

Drug: Prednisone

Drug: Cyclosporine

Drug: Ruxolitinib