Nivolumab Maintenance for Newly Diagnosed Primary Central Nervous System Lymphoma with Persistent Tumor DNA in Spinal Fluid After First Chemotherapy
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
Inactive
ClinicalTrials ID:NCT04401774
This study is testing if the drug nivolumab can safely prevent the return of primary central nervous system lymphoma (PCNSL) in patients who still have tumor DNA in their spinal fluid after completing their first chemotherapy treatment.
Patient Parameters
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Program Overview
The aim of this study is to see if nivolumab can help stop primary central nervous system lymphoma (PCNSL) from coming back in patients who still have tumor DNA in their spinal fluid after finishing their initial chemotherapy treatment. Nivolumab is being tested to ensure it is safe and effective for this purpose.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of primary central nervous system lymphoma (PCNSL) and be able to provide tissue samples from the initial diagnosis.
- Must be able to undergo MRI or CT scans and lumbar punctures.
- Must still have tumor DNA in the spinal fluid after first-line chemotherapy.
- Must be able to understand and sign a consent form.
- Must be 18 years or older.
- Must have a Karnofsky Performance Status (KPS) score of 60 or higher, indicating the ability to care for oneself.
- Must have a life expectancy of more than 3 months.
- Must have adequate bone marrow and organ function, as shown by specific blood test results.
- Women of childbearing potential must use effective birth control during treatment and for 5 months after. Men must use effective contraception during treatment and for 7 months after.
- Women must have a negative pregnancy test before starting the study.
Exclusion Criteria
- Cannot have recurrent or refractory PCNSL or stable disease as the best response to first-line chemotherapy.
- Cannot have systemic lymphoma that has spread to the central nervous system.
- Cannot have HIV, hepatitis B, or hepatitis C infections.
- Cannot be planning to undergo a stem cell transplant.
- Cannot have had a previous allogenic stem cell transplant.
- Cannot have received chemotherapy, radiation, or anticancer antibodies within 14 days of starting the study drug.
- Cannot be allergic to nivolumab or its components.
- Cannot be using other cancer treatments or have had previous treatments with certain immune therapies.
- Cannot have another active cancer requiring treatment.
- Cannot be on high doses of steroids or other immunosuppressive medications.
- Cannot have an active autoimmune disease requiring treatment in the past 2 years.
- Cannot have a history of lung inflammation or significant heart problems.
- Cannot have recent severe gastrointestinal issues.
- Cannot have an uncontrolled infection or other serious medical conditions.
- Cannot be pregnant or breastfeeding.
- Cannot have received a live vaccine within 30 days of starting treatment.
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