A Study to Evaluate the Efficacy and Safety of the Sintilimab Plus ICE Regimen Versus ICE Regimen in the Classic Hodgkin's Lymphoma Patients (cHL) Who Have Failed the First-line Standard Chemotherapy

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase III trial studies the side effects of sintilimab and to see how well it works when given together with ifosfamide, carboplatin, and etoposide in treating patients with classic Hodgkin lymphoma that does not respond to first-line standard chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Carboplatin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard

Criteria

Inclusion Criteria:

1. Patients who sign the informed consent form.

2. Patients must have histopathologically confirmed cHL.

3. Patients must have not respond to the first-line standard combination chemotherapy.

4. Patients must have one measurable lesion (Lugano2014).

5. Eastern Cooperative Oncology Group (ECOG) of 0-1.

6. Male or female aged ≥18 years.

7. Patients must have adequate organ and bone marrow function.

Exclusion Criteria:

1. Patients must not have known central nervous system (CNS) involvement.

2. Patients must not have had prior exposure to any immune checkpoint inhibitors including anti-PD-L1 gents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies.

3. Patients must not have participate in another interventional clinical study at the same time.

4. Patients must not be currently receiving any other investigational agents within 4 weeks of study registration.

5. Patients must not have received any other form of immunosuppressive therapy within 4 weeks prior to the first dose of the study.

6. Patients must not have received live attenuated vaccines within 4 weeks prior to the first dose (or plan to receive live attenuated vaccines during the study period).

7. Patients with known immunodeficiency are ineligible .

8. Patients with known active TB (Bacillus tuberculosis) are not eligible.

9. Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation.

10. Patients must not be pregnant or breastfeeding.