Maintenance Treatment Versus Observation in Elderly Patients With PCNS Lymphoma

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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

• Treatment of the elderly is challenging, indeed age over 60 is associated both with a poor prognosis and a high risk of treatment induced neurotoxicity with devastating consequences on quality of life. Therefore it has become standard practice to treat elderly in first line with high-dose methotrexate (MTX) based polychemotherapy alone, avoiding whole brain radiotherapy (WBRT) or deferring it for recurrence.

• There is a clear need to improve disease control after induction chemotherapy. Since consolidation with WBRT or intensive chemotherapy with autologous stem cell rescue are either poorly effective and/or too toxic in the elderly population, maintenance chemotherapy is an interesting alternative approach. Several agents, such as high-dose MTX, temozolomide (TMZ), rituximab, with a reported activity in PCNSL and acceptable safety profile, as single agent or combined, are good candidates for maintenance

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Methotrexate; Rituximab; Temozolomide

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