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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab for Injection | Experimental | Participants receive Camrelizumab 200mg intravenously (IV) on Day 1 of each 2-week cycle |
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| Chemotherapy | Active Comparator | Participants receive investigator's choice of chemotherapy (Gemox, IGEV or DHAP) for up to 6 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | A humanized monoclonal immunoglobulin |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Time from randomisation to radiologically confirmed progressive disease | anticipated 16 months |
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Inclusion Criteria:
With histologically confirmed classic Hodgkin's lymphoma ;
Relapsed or refractory cHL meet either of the following criteria:
Have measurable disease according to Lugano 2014 criteria
Eastern Cooperative Oncology Group (ECOG) performance scale of 0 or 1;
Life expectancy ≥ 12 weeks;
Has adequate organ function;
Women of childbearing potential(WOCBP) must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 60 days after the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation. Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment.
Able to understand and sign an informed consent form (ICF).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiwei Wang, Ph.D. | Contact | 86-021-23511999 | wangweiwei@hrglobe.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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| 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. |
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