A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.

Sponsor
Hoffmann-La Roche
Study ID
NCT00517699
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Key Dates

Start date
Sep 30, 2007
Status verified
Jul 2014
Primary completion
Mar 31, 2009
Completion
Mar 31, 2009

Study Design

Enrollment
5 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu) [ Time Frame: Week 24 ]

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