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.
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/m²; 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 response must be obtained within 30 days before randomization
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
Clinical evidence of extra-central nervous system (CNS) (systemic) non-Hodgkin lymphoma
Known hypersensitivity to any of the study drugs
History of other malignancy that could affect compliance with the protocol or interpretation of results
Parallel
Cognitive Assessment
Procedure/SurgeryAncillary studies to evaluate neurocognitive function at study entry and at 2 years after study entry.
Obinutuzumab
Biological/VaccineGiven IV
Quality of Life Assessment
Other interventionAncillary studies to evaluate quality of life at study entry and at 2 years after study entry.
Partial response (PR) or complete response (CR) duration
PR or CR duration will be assessed using Kaplan-Meier product limit estimates and compared between patients with maintenance versus without obinutuzumab maintenance using the log-rank test. In addition, the Cox proportional hazard model will be used to estimate hazard ratios.
Overall survival (OS) after CR
OS after PR or CR will be assessed using Kaplan-Meier product limit estimates and compared between patients with maintenance versus without obinutuzumab maintenance using the log-rank test. In addition, the Cox proportional hazard model will be used to estimate hazard ratios.
Neurocognitive function - Wechsler Adult Intelligence Scale
Will be measured by the Wechsler Adult Intelligence Scale. Scale range 0 to 16 Forward; 0 to 14 Backward. Higher the score means better outcome. Longitudinal data of neurocognitive function will be analyzed using a linear mixed model and toxicity indicators will be assessed using a chi-square or exact test.
Quality of life (QOL) - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain Neoplasm 20-item
Will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Brain Cancer Module-20 (EORTC QLQ-BN20) questionnaire. Scale 20 to 80 points. Higher score means worse outcome. Longitudinal data of QOL will be analyzed using a linear mixed model and toxicity indicators will be assessed using a chi-square or exact test.
Progression free survival (PFS)
PFS will be assessed using Kaplan-Meier product limit estimates and compared between patients with obinutuzumab maintenance versus without maintenance using the log-rank test. Longitudinal data of neurocognitive function and QOL will be analyzed using a linear mixed model and toxicity indicators will be assessed using a chi-square or exact test.
Click on the lead sponsor to view all of their trials.
