Status:
UNKNOWN
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
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Classic Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
randomized, double-blind, two arms , multicenter
Eligibility Criteria
Inclusion
- Signed informed consent
- Histopathologically confirmed cHL
- Failed first-line standard combination chemotherapy
- One measurable lesion (Lugano 2014)
- Eastern Cooperative Oncology Group (ECOG) of 0-1
- Male or female aged ≥18 years
- Patients must have adequate organ and bone marrow function
Exclusion
- Patients must not have known central nervous system (CNS) involvement
- 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
- Patients may not simultaneously participate in another interventional clinical study
- Patients may not receive any other investigational agents within 4 weeks of study registration
- Patients may not receive any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug
- 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)
- Patients with known immunodeficiency are ineligible
- Patients with known active TB (Bacillus tuberculosis) are ineligible
- Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation
- Patients must not be pregnant or breastfeeding
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04044222
Start Date
October 21 2019
End Date
December 31 2024
Last Update
September 14 2022
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China