Trial intelligence / Profile preview

Rituximab + Chemotherapy in Primary CNS Lymphoma

NCT00335140Phase 2

Key facts

Status
Terminated
Start
Aug 2007
Primary completion
Jul 2015
Countries
1
Sponsor
Eastern Cooperative Oncology Group
Modality
Monoclonal Antibodies
Conditions
primary central nervous system lymphoma (PCNSL)
01

Overview

Phase 2, open-label, single-arm trial of rituximab in primary central nervous system lymphoma (PCNSL), sponsored by Eastern Cooperative Oncology Group. Primary endpoint: Complete Response Rate at 17 weeks. Started Aug 2007; status: terminated.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Rituximab + standard chemotherapy

    Rituximab combined with high-dose methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine.

03

Who it enrols

Adult patients with histologically confirmed primary CNS lymphoma, ECOG PS 0-3, and adequate organ function. Excludes patients with HIV, prior PCNSL therapy, or systemic lymphoma.

04

Endpoints

Primary

  • Complete Response Rate

Secondary

  • Progression-Free Survival

  • Overall Survival

  • Rituximab Cerebrospinal Fluid Pharmacokinetics

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