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

Launched by BEIJING SANBO BRAIN HOSPITAL · Aug 25, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a medication called camrelizumab to see if it can help patients with recurrent primary central nervous system lymphoma (PCNSL) respond better to treatment. PCNSL is a type of cancer that affects the brain and spinal cord. The trial aims to find out if camrelizumab can improve the chances of patients experiencing a positive response to their treatment after their cancer has come back. The study is currently looking for participants aged 18 and older who have already been diagnosed with this type of lymphoma and have experienced a recurrence, as confirmed by MRI scans.

To be eligible for the trial, participants need to have a measurable tumor, a reasonable life expectancy, and normal function in key organs. They should not be receiving other cancer treatments at the same time or have certain medical conditions, like autoimmune diseases. Participants who join the study will be closely monitored and will have the chance to contribute to research that could lead to better treatments for PCNSL in the future. If you or someone you know is interested in learning more about this study, it's important to discuss it with a healthcare provider.

Gender

ALL

Eligibility 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;