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

NCT06364319 | Not Yet Recruiting Phase 4

• 1 other identifier: 2024PHD002-001
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

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

Conditions

cGVHD

Outcome Measures

Primary Outcomes (1)

• overall response rate (ORR)

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

  56 days

Secondary Outcomes (7)

• duration of response（DOR）

  1 year

• patient-reported outcomes (PRO)

  1 year

• disease-free survival (DFS)

  1 year

• failure-free survival (FFS)

  1 year

• non-relapse mortality (NRM)

  1 year

Study Arms (2)

Anti-CD25 rhMAb + traditional therapy

EXPERIMENTAL

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

traditional therapy

PLACEBO COMPARATOR

Drug: Prednisone; Drug: Ruxolitinib; Drug: Cyclosporine

Interventions

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.

Anti-CD25 rhMAb + traditional therapy

Prednisone DRUG

Maintain pre-screening dose

Anti-CD25 rhMAb + traditional therapy; traditional therapy

Ruxolitinib DRUG

10mg, BID PO

Anti-CD25 rhMAb + traditional therapy; traditional therapy

Cyclosporine DRUG

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

Anti-CD25 rhMAb + traditional therapy; traditional therapy

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Received ≤4 lines of systemic therapy prior to screening
• After informed consent, the patient agreed to receive anti-CD25 rhMAb treatment

You may not qualify if:

• Elevation of bilirubin, ALT, or alkaline phosphatase due to reasons other than chronic GVHD
• No prior treatment with prednisone
• Overlap syndrome
• Uncontrolled active infection
• Organ failure
• Early progression or recurrence of hematologic diseases
• Allergy to anti-CD25 rhMAb
• Received other interleukin-2 receptor monoclonal antibody treatment due to various reasons within one month after transplantation
• Participated in other clinical studies within one month

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Interventions

Prednisone; ruxolitinib; Cyclosporine

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 15, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 15, 2024

Record last verified: 2024-04