Status:
UNKNOWN
Maintenance Treatment Versus Observation in Elderly Patients With PCNS Lymphoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
Hypothesis Our hypothesis is that maintenance chemotherapy will prolong complete remission obtained after a standard induction chemotherapy with an acceptable toxicity in the elderly. Rationale * T...
Detailed Description
Objectives * The primary objective is to evaluate the benefit estimated by the PFS associated with maintenance chemotherapy compared to observation in patients ≥ 60 years having achieved a complete r...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
428 Patients enrolled
Trial Details
Trial ID
NCT02313389
Start Date
September 1 2015
End Date
April 1 2023
Last Update
March 2 2022
Active Locations (1)
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1
Groupe Hospitalier Pitie Salpetriere
Paris, France, 75013