- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04239170
Camrelizumab(SHR-1210) Combined With GEMOX in Patients With Relapsed or Refractory Hodgkin Lymphoma
January 22, 2020 updated by: Jun Zhu, Peking University
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
84
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuqin Song, MD
- Phone Number: (+8610)88196118
- Email: SongYQ_VIP@163.com
Study Locations
-
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Beijing
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Beijing, Beijing, China
- Recruiting
- Beijing Cancer Hospital
-
Contact:
- Jun Zhu, MD
- Phone Number: (+8610)88196596
- Email: Zj@bjcancer.org
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Camrelizumab(SHR-1210) Combined With GEMOX
|
Camrelizumab(SHR-1210): A humanized monoclonal immunoglobulin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response
Time Frame: From first patient first visit to 3 month after last patient first visit
|
Based on Lugano 2014 criteria
|
From first patient first visit to 3 month after last patient first visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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From first patient first visit to 3 month after last patient first visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
January 1, 2020
Primary Completion (ANTICIPATED)
December 1, 2022
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
January 20, 2020
First Submitted That Met QC Criteria
January 22, 2020
First Posted (ACTUAL)
January 23, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 23, 2020
Last Update Submitted That Met QC Criteria
January 22, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Hodgkin Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Oxaliplatin
Other Study ID Numbers
- SHR-1210-GEMOX-IIT-HL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedStage III Childhood Hodgkin Lymphoma | Stage IV Childhood Hodgkin Lymphoma | Stage I Childhood Hodgkin Lymphoma | Stage II Childhood Hodgkin Lymphoma | Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma | Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma | Childhood Mixed Cellularity... and other conditionsUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland, Israel
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