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

Innovent Biologics

Status and phase: Enrolling; Phase 3

Conditions: Classic Hodgkin's Lymphoma

Treatments: Drug: Carboplatin; Drug: Placebo; Drug: Etoposide; Biological: Sintilimab; Drug: Ifosfamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04044222

CIBI308B301

Details and patient eligibility

About

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.

Full description

randomized, double-blind, two arms , multicenter

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)

Experimental group

Description:

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:

Drug: Carboplatin

Drug: Etoposide

Biological: Sintilimab

Drug: Ifosfamide

Drug: Etoposide

Drug: Ifosfamide

Drug: Carboplatin

Treatment (placebo, etoposide, ifosfamide, carboplatin)

Experimental group

Description:

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:

Drug: Carboplatin

Drug: Placebo

Drug: Etoposide

Drug: Ifosfamide

Drug: Etoposide

Drug: Ifosfamide

Drug: Carboplatin