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

First listed
Oct 5, 2009
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