Maintenance Treatment Versus Observation in Elderly Patients With PCNS Lymphoma (BLOCAGE-01)
Primary Central Nervous System Lymphoma
About this trial
This is an interventional treatment trial for Primary Central Nervous System Lymphoma
Eligibility Criteria
Inclusion criteria At registration Inclusion criteria
- newly diagnosed primary cerebral lymphoma
- Age ≥60 years
- Pathology proven diagnosis or positive cytology of the CSF or vitreous
- Karnofsky Performance Status ≥40
- No evidence of systemic NHL (body CT scan, bone marrow biopsy)
- Adequate haematological, renal and hepatic function
- Calculated creatinine clearance > 40 ml/min
At randomization
- Complete response on MRI after induction chemotherapy according to the IPCG criteria
- Karnofsky Performance Status ≥40
- Adequate haematological, renal and hepatic function
Exclusion criteria
- Positive HIV serology
- Preexisting immunodeficiency (organ transplant recipient)
- Prior treatment for PCNSL
- Isolated primary intra-ocular lymphoma
- Low grade lymphoma
- Any other active primary malignancy
Sites / Locations
- Groupe Hospitalier Pitie Salpetriere
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
maintenance chemotherapy
observation
Clinical examination and MRI will be performed every 3 months for 2 years and then every 6 months until tumor progression. Neurocognitive tests will be performed at randomization and annually. Quality of life questionnaires at randomisation and every 3 months
Clinical examination and MRI will be performed every 3 months for 2 years and then every 6 months until tumor progression. Neurocognitive tests will be performed at randomization and annually. Quality of life questionnaires at randomisation and every 3 months