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

Phase 3

Recruiting

• Conditions: Classic Hodgkin's Lymphoma
• Interventions: Biological: Sintilimab; Drug: Placebo; Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide

• Registration Number: NCT04044222
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

This phase III trial studies the side effects of sintilimab 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.

Detailed Description

randomized, double-blind, two arms , multicenter

Study Timeline

• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-05
• Study Start: 2019-10-21
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-14
• Primary Completion: 2023-07-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Signed informed consent
2. Histopathologically confirmed cHL
3. Failed first-line standard combination chemotherapy
4. One measurable lesion (Lugano 2014)
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 agents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies
3. Patients may not simultaneously participate in another interventional clinical study
4. Patients may not receive any other investigational agents within 4 weeks of study registration
5. Patients may not receive any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug
6. Patients may not receive live attenuated vaccines within 4 weeks prior to the first dose of study drug (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 ineligible
9. Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation
10. Patients must not be pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)	Sintilimab	Patients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses.
Treatment (placebo, etoposide, ifosfamide, carboplatin)	Placebo	Patients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses.
Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)	Ifosfamide	Patients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses.
Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)	Carboplatin	Patients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses.
Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)	Etoposide	Patients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses.
Treatment (placebo, etoposide, ifosfamide, carboplatin)	Etoposide	Patients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses.
Treatment (placebo, etoposide, ifosfamide, carboplatin)	Carboplatin	Patients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses.
Treatment (placebo, etoposide, ifosfamide, carboplatin)	Ifosfamide	Patients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses.

Primary Outcome Measures

Name	Time	Method
PFS	44months

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China