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
  • End date
    Dec 31, 2024
  • participants needed
    240
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 25 January 2021

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.

Description

randomized, double-blind, two arms , multicenter

Details
Condition Classic Hodgkin's Lymphoma
Treatment etoposide, ifosfamide, carboplatin, Placebo, Sintilimab
Clinical Study IdentifierNCT04044222
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who sign the informed consent form
Patients must have histopathologically confirmed cHL
Patients must have not respond to the first-line standard combination chemotherapy
Patients must have one measurable lesion (Lugano2014)
Eastern Cooperative Oncology Group (ECOG) of 0-1
Male or female aged 18 years
Patients must have adequate organ and bone marrow function

Exclusion Criteria

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 gents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies
Patients must not have participate in another interventional clinical study at the same time
Patients must not be currently receiving any other investigational agents within 4 weeks of study registration
Patients must not have received any other form of immunosuppressive therapy within 4 weeks prior to the first dose of the study
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)
Patients with known immunodeficiency are ineligible
Patients with known active TB (Bacillus tuberculosis) are not eligible
Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation
Patients must not be pregnant or breastfeeding
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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