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This is an open-label, single arm, Phase 2 study to evaluate efficacy and safety of PD1 inhibitor Camrelizumab(SHR-1210) combined with Gemox in patients with relapsed and refractory hodgkin lymphoma who will receive ASCT.Efficacy will be assessed according to 2014 Lugano criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab(SHR-1210) Combined With GEMOX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab(SHR-1210) | Drug | Camrelizumab(SHR-1210): A humanized monoclonal immunoglobulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response | Based on Lugano 2014 criteria | From first patient first visit to 3 month after last patient first visit |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Rate of subjects achieved complete response plus partial response in all evaluable subjects | From first patient first visit to 3 month after last patient first visit |
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Inclusion Criteria:
Histologically confirmed classic Hodgkin's lymphoma ;
Relapsed or refractory cHL and meet any of the following criterions:a)did not achieve remission or progression and will receive autologous hematopoietic stem cell transplantation.b)receive no more than 3 lines of systemic chemotherapy.
Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
ECOG performance status of 0 or 1;
Life expectancy ≥ 12 weeks.;
Adequate laboratory parameters during the screening period as evidenced by the following:
Women of childbearing potential(WOCBP)with pregnancy test negative within 7 days before entering the group and consent to employ a highly effective method of birth control/contraception to prevent pregnancy for at least 1 year after receiving the last dose of study treatment; Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy for at least 1 year after receiving the last dose of study treatment.
Able to understand and sign an informed consent form (ICF).
Exclusion Criteria:
Known nodular lymphoma predominant Hodgkin lymphoma
History and complication as follows,
Laboratory test
Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection.
Pregnant or lactating women.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuqin Song, MD | Contact | (+8610)88196118 | SongYQ_VIP@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38454451 | Derived | Liu Y, Ping L, Song Y, Tang Y, Zheng W, Liu W, Ying Z, Zhang C, Wu M, Feng F, Lin N, Tu M, Zhu J, Xie Y. Camrelizumab plus gemcitabine and oxaliplatin for relapsed or refractory classical Hodgkin lymphoma: a phase II trial. BMC Med. 2024 Mar 7;22(1):107. doi: 10.1186/s12916-024-03329-8. |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |