Trials / Unknown
UnknownNCT04342936
Study of Camrelizumab (SHR-1210) vs. Chemotherapy in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
A Randomized,Open-label Phase III Study of Camrelizumab (SHR-1210) vs. Investigator's Choice of Chemotherapy in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Camrelizumab | A humanized monoclonal immunoglobulin |
| DRUG | Investigator's choice of Chemotherapy | 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. |
Timeline
- Start date
- 2020-07-17
- Primary completion
- 2023-08-01
- Completion
- 2023-12-01
- First posted
- 2020-04-13
- Last updated
- 2021-02-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04342936. Inclusion in this directory is not an endorsement.