A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis
A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis
The purpose of this study is to define the safety profile of rituximab given intrathecally in
 lymphomatous meningitis related to CD20+ non-Hodgkin's lymphomas.
Inclusion Criteria:

 1. Lymphomatous meningitis documented by positive CSF cytology in either newly diagnosed,
 relapsed or refractory primary CNS or systemic NHL

 2. Pathologically diagnosed CD20-positive NHL

 3. Age ≥ 18 years

 4. ECOG Performance Status 0 - 2 (See Appendix A)

 5. Life expectancy of at least 1 month

 6. Informed consent must be given according to national/local regulations before
 enrollment (See Appendix B)

 7. Patients may have had prior CNS irradiation, intrathecal methotrexate, cytarabine or
 thiotepa for treatment of lymphomatous meningitis but these treatments must have
 completed at least two weeks before the study enrollment and the patients must have
 recovered from any reversible toxicity caused by prior treatments

 8. Concurrent systemic chemotherapy is allowed with the exception of high-dose
 methotrexate (>500 mg/m2/day), high-dose cytarabine (>2 g/m2/day), high-dose thiotepa
 (>300 mg/m2/day) or investigational agents

 9. No concurrent intrathecal chemotherapy other than rituximab

 10. No severe impairment of bone marrow function (ANC >1.5x109/L, PLT >50x109/L), unless
 due to proven lymphoma involvement

 11. No major impairment of renal function (serum creatinine < 1,5 x upper normal) or liver
 function (ASAT/ALAT < 2,5 upper normal, total bilirubin <2,5x upper normal), unless
 due to proven lymphoma involvement

 12. No evidence of active opportunistic infections

 13. No HIV infection

 14. No pregnant or lactating status

 15. Appropriate contraceptive method in women of childbearing potential or men

 16. Absence of any psychological, familial, sociological or geographical condition
 potentially hampering compliance with the study protocol and follow-up schedule; those
 conditions should be discussed with the patient before registration in the trial

 17. Absence of a obstructive hydrocephalus or compartimentalization of CSF flow.