Camrelizumab(SHR-1210) Combined With GEMOX in Patients With Relapsed or Refractory Hodgkin Lymphoma
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ClinicalTrials.gov Identifier: NCT04239170 |
Recruitment Status : Unknown
Verified January 2020 by Jun Zhu, Peking University.
Recruitment status was: Recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hodgkin Lymphoma | Drug: Camrelizumab(SHR-1210) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 84 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-lable, Single Arm, Phase 2 Study of Camrelizumab(SHR-1210) Combined With GEMOX in Patients With Relapsed or Refractory Hodgkin Lymphoma Who Will Receive ASCT |
Estimated Study Start Date : | January 2020 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Camrelizumab(SHR-1210) Combined With GEMOX |
Drug: Camrelizumab(SHR-1210)
Camrelizumab(SHR-1210): A humanized monoclonal immunoglobulin
Other Name: GEMOX(Gemcitabine, Oxaliplatin) |
- Complete Response [ Time Frame: From first patient first visit to 3 month after last patient first visit ]Based on Lugano 2014 criteria
- Objective Response Rate [ Time Frame: From first patient first visit to 3 month after last patient first visit ]Rate of subjects achieved complete response plus partial response in all evaluable subjects
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.;
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Adequate laboratory parameters during the screening period as evidenced by the following:
- Hemoglobin ≥ 90 g/L;
- Absolute neutrophil count ≥ 1.5 × 109/L ;
- Platelets ≥ 100 × 109/L;
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN),
- ALT and AST ≤ 2.5×ULN
- Serum Creatinine ≤1.25×ULN or Creatinine clearance≥60 mL/min;
- Coagulation function index:INR ≤1.5×ULN,APTT≤1.5×ULN
- 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,
- Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted
- Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids > 10 mg/day topical prednisone or equivalent are prohibited within 2 weeks before entering the group
- Received anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months before the first dose of trial drugs.
- Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody . Or prior exposure to GEMOX but PD.
- Participating in other clinical studies or less than 4 weeks before the end of a clinical trial.
- Known and highly Suspicion of interstitial pneumonia.
- Other active malignancies that required treating. (subjects with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma who had no disease recurrence within 5 years after the start of treatment were excluded).
- Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except hair loss) did not recover to CTCAE ≤1.
- Prior allo-HSCT.
- Impact of major surgery or severe trauma had been eliminated for less than 28 days
- Active pulmonary tuberculosis.
- Severe acute or chronic infection requiring systemic therapy.
- Suffering from high blood pressure, and cannot be well controlled by antihypertensive drugs (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg)
- Suffering from heart failure (New York Heart Association standard III or IV). Uncontrolled coronary artery disease and arrhythmia although given appropriate medical treatment. History of myocardial infarction within 6 months.
- Three months before randomization, there were significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, stool occult blood test is ++ at baseline and above, or vasculitis
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Laboratory test
- Known HIV positive or known AIDS.
- Untreated active hepatitis: Hepatitis B(HBsAg positive and HBV DNA≥500IU/mL), and hepatitis C(HCV RNA positive, abnormal liver function) ,Hepatitis B and hepatitis C infection in common.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239170
Contact: Yuqin Song, MD | (+8610)88196118 | SongYQ_VIP@163.com |
China, Beijing | |
Beijing Cancer Hospital | Recruiting |
Beijing, Beijing, China | |
Contact: Jun Zhu, MD (+8610)88196596 Zj@bjcancer.org |
Responsible Party: | Jun Zhu, Party secretary of Cancer Hospital of Peking University, Director of Internal Medicine, Peking University |
ClinicalTrials.gov Identifier: | NCT04239170 |
Other Study ID Numbers: |
SHR-1210-GEMOX-IIT-HL |
First Posted: | January 23, 2020 Key Record Dates |
Last Update Posted: | January 23, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Gemcitabine Oxaliplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |