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

cGVHD Clinical Trial

Official title:

Study on the Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease (cGVHD) of the Liver Following Allogeneic Hematopoietic Stem Cell Transplantatio

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364319
• Other study ID #: 2024PHD002-001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 15, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: April 2024
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: June 30, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• cGVHD

Intervention

Drug:
• anti-CD25 rhMAb
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
Maintain pre-screening dose
• Ruxolitinib
10mg, BID PO
• Cyclosporine
1.25mg/kg, BID PO/IV, target:150-250ng/ml

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate (ORR)	ORR is defined as the percentage of complete response (CR) and partial response (PR).	56 days
Secondary	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.	1 year
Secondary	patient-reported outcomes (PRO)	Based on the Lee Chronic GVHD Symptom Scale.	1 year
Secondary	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.	1 year
Secondary	failure-free survival (FFS)	Events that are considered as failures include the onset of new chronic GVHD, relapse, and death.	1 year
Secondary	non-relapse mortality (NRM)	NRM is defined as death due to reasons other than progression/relapse of hematologic disease.	1 year
Secondary	overall survival (OS)	OS is defined as the time from treatment until death from any cause or the last follow-up.	1 year
Secondary	adverse drug reactions (ADR)	The occurrence of various organ toxicities related to treatment that emerge following treatment.	1 year