Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Hav
This randomized phase II trial studies how well obinutuzumab works as maintenance treatment in patients with central nervous system lymphoma who have achieved the disappearance of all signs of cancer in response to treatment (complete response) or a decrease in the size of a tumor, or in the extent of cancer in the bod
| Condition(s) | Primary Central Nervous System Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This randomized phase II trial studies how well obinutuzumab works as maintenance treatment in patients with central nervous system lymphoma who have achieved the disappearance of all signs of cancer in response to treatment (complete response) or a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment (partial response). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. |
| Who can participate | Inclusion Criteria: * CD20+ B-cell primary central nervous system lymphoma (PCNSL) confirmed at the time of diagnosis by histology, cytology, or immunocytochemistry from cerebrospinal fluid (CSF); diagnosis must be documented by pathology report. * Must have undergone first-line treatment with a high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy; high-dose methotrexate is defined as \>= 3 grams/m\^2; methotrexate dose reduction for creatinine clearance \< 100 ml/min is permitted * Must be within 75 days of completion of first-line treatment regimen at the time of randomization; must have achieved objective response (PR or CR/unconfirmed complete response \[CRu\]) to first-line treatment * Brain magnetic resonance imaging (MRI) documenting objective respons |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Providence Health & Services |
| Locations | New York, New York, United States; Cleveland, Ohio, United States; Portland, Oregon, United States; Hershey, Pennsylvania, United States; Burlington, Vermont, United States; Charlottesville, Virginia, United States (+1 more sites) |
| Start date | 2024-03-13 |
| NCT ID | NCT06175000 |
| Official listing | https://clinicaltrials.gov/study/NCT06175000 |