Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma

Sponsor
University Hospital Freiburg
Study ID
NCT00989352
Phase
PHASE2
Status
Unknown

Conditions

  • Primary Non Hodgkin Lymphoma of the Central Nervous System

Eligibility Criteria

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

Interventions

  • Methotrexate — DRUG
    3g/m² i.v. max. 9 times
  • Lomustine — DRUG
    110 mg/m² p.o., max. 3 times
  • Procarbazine — DRUG
    60 mg/m² p.o. for 10 days, max. 3 times 100 mg p.o. for 5 days, max. 6 times
  • Rituximab — DRUG
    375 mg/m² i.v., max. 10 times

Study Details

The purpose of this study is to determine whether combined chemotherapy \[rituximab plus high dosage methotrexate, lomustine, and procarbazine\] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma \[PCNSL\] in patients \> 65 years.

Key Dates

Start date
Sep 30, 2009
Status verified
Oct 2009
Primary completion
Jun 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Complete remission rate [ Time Frame: 30 days after end of immuno-chemotherapy ]

Central Contacts