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Camrelizumab for Patients With Recurrent Primary Central Nervous System Lymphoma (PCNSL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04070040
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Junping Zhang, Beijing Sanbo Brain Hospital

Brief Summary:
This study is intend to improve the objective response rate in treatment of camrelizumab in recurrent primary central nervous system lymphoma patients.

Condition or disease Intervention/treatment Phase
Primary Central Nervous System Lymphoma Drug: Camrelizumab Phase 2

Detailed Description:
Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with recurrent PCNSL remains challenging and at present there is no universally accepted therapeutic approach . The purpose of this study is to evaluate the efficacy and safety of camrelizumab [a programmed cell death 1 (PD-1) inhibitor] for recurrent patients with primary CNS lymphoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study on Camrelizumab(SHR-1210)for Recurrent Primary Central Nervous System Lymphoma (PCNSL)
Estimated Study Start Date : March 15, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Camrelizumab
Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.
Drug: Camrelizumab
Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.
Other Name: SHR-1210




Primary Outcome Measures :
  1. ORR(objective response rate) [ Time Frame: Up to three years ]
    the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period


Secondary Outcome Measures :
  1. The best therapeutic response of CR(complete response)、PR(partial response)、SD(stable response) and PD(progressive disease) [ Time Frame: Up to three years ]
    Describe the best therapeutic response of patients treated with Camrelizumab

  2. PFS(progression free survival) [ Time Frame: Up to three years ]
    the time from randomization until objective tumor progression or death

  3. OS(overall survival) [ Time Frame: Up to three years ]
    the time from randomization until death from any cause and is measured in the intent-to-treat population

  4. ADEs( adverse events) [ Time Frame: Up to three years ]
    Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity.

  5. KPS(Karnofsky Performance Status) [ Time Frame: Up to three years ]
    Duration of stabilization/improvement of Karnofsky Performance Status



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The initial diagnosis was primary diffuse large B-cell lymphoma of the central nervous system confirmed by histopathology;
  2. Prior to first-line treatment based on methotrexate (with or without radiotherapy), tumor recurrence was confirmed by MRI;
  3. Measurable focus in MRI (>10x10mm);
  4. Aged > 18 years;
  5. Life expectancy of at least 12 weeks;
  6. The patient has a Karnofsky performance status of at least 50%;
  7. Main organs function normally, without serious blood, heart, lung, liver, kidney and immune deficiency diseases. Specific assay indicators requirements: White blood cells>3.0×10^9/L;platelet>80×10^9/L;hemoglobin>10g/dL;serum bilirubin ≤ 1.5×ULN;ALT and AST ≤ 2×ULN;serum creatinine≤1.5mg/dL;
  8. Female subjects of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (eg, IUD, contraceptive or condom) during the study period and within 3 months of the last study drug administration;
  9. The subject should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form;

Exclusion Criteria:

  1. Concurrent administration of any other antitumor therapy;
  2. Allergic to the ingredients of research drugs;
  3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent;
  4. Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function;
  5. Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, except for a maximum dose of 4 mg/day dexamethasone or equivalent doses of other corticosteroids or control of brain edema, which has been stable or decreased for at least 1 week prior to inclusion;
  6. Active infection;
  7. Risk of bleeding;
  8. HIV positivity;
  9. Pregnancy and lactation;

Information from the National Library of Medicine

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): NCT04070040


Locations
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China
Sanbo Brain Hospital Capital Medical University Recruiting
Beijing, China
Contact: Jun-ping Zhang    86-010-62856783    doczhjp@hotmail.com   
Sponsors and Collaborators
Beijing Sanbo Brain Hospital

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Responsible Party: Junping Zhang, Beijing Sanbo Brain Hospital
ClinicalTrials.gov Identifier: NCT04070040    
Other Study ID Numbers: 1.0
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases