A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoma, B Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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intrathecal rituximab

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No