Study of Camrelizumab (SHR-1210) vs. Chemotherapy in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04342936
Phase
PHASE3
Status
Unknown

Conditions

  • Classical Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    A humanized monoclonal immunoglobulin
  • Investigator's choice of Chemotherapy — DRUG
    Participants will receive one of the following chemotherapies for up to 6 cycles: Gemox: Gemcitabine and Oxaliplatin； IGEV: Ifosfamide, Gemcitabine, Vinorelbine, and Prednisolone； DHAP: Dexamethasone, high-dose Cytarabine (Ara-C) and Cisplatin.

Study Details

This is an open-label, multicenter, randomized, phase3 trial to evaluate the efficacy of Camrelizumab in patients with relapsed or refractory classic Hodgkin's lymphoma. Participants will be randomized to receive either Camrelizumab monotherapy or chemotherapy of investigators' choice. The primary hypotheses of this study are that treatment with Camrelizumab prolongs Progression-free Survival (PFS) in participants with relapsed or refractory Classical Hodgkin Lymphoma compared to treatment with Chemotherapy.

Key Dates

Start date
Jul 17, 2020
Status verified
Apr 2020
Primary completion
Aug 1, 2023
Completion
Dec 1, 2023

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab for Injection
    Participants receive Camrelizumab 200mg intravenously (IV) on Day 1 of each 2-week cycle
  • Active Comparator: Chemotherapy
    Participants receive investigator's choice of chemotherapy (Gemox, IGEV or DHAP) for up to 6 cycles.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: anticipated 16 months ]

Central Contacts

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