Maintenance Obinutuzumab for Primary Central Nervous System Lymphoma Complete or Partial Responders
Providence Health & Services
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.
Description
PRIMARY OBJECTIVE: I. To determine the effect of maintenance obinutuzumab on duration of response (partial response \[PR\] or complete response \[CR\]) in patients with CD20+ B-cell primary central nervous system lymphoma (PCNSL) who attain PR or CR to first-line treatment with high-dose methotrexate-based chemotherapy. SECONDARY OBJECTIVES: I. To evaluate overall survival after PR or CR (overall survival \[OS\]-PRCR). II. To evaluate neurocognitive function, quality of life, and neuroimaging as indicators of neurotoxicity. III. Progression-free survival (PFS) and overall survival (OS) wil…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 tim…
Interventions
- ProcedureCognitive Assessment
Ancillary studies to evaluate neurocognitive function at study entry and at 2 years after study entry.
- BiologicalObinutuzumab
Given IV
- OtherQuality of Life Assessment
Ancillary studies to evaluate quality of life at study entry and at 2 years after study entry.
Locations (7)
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Cleveland ClinicCleveland, Ohio
- Providence Health & Services; Providence Neurological SpecialtiesPortland, Oregon
- Pennsylvania State UniversityHershey, Pennsylvania
- University of VermontBurlington, Vermont
- University of VirginiaCharlottesville, Virginia