Freiburg ZNS-NHL Study

Sponsor
University Hospital Freiburg
Study ID
NCT00647049
Phase
PHASE2
Status
Unknown

Conditions

  • Primary Non Hodgkin Lymphoma of the Central Nervous System

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • methotrexate — DRUG
    8000mg/m2 i.v., max. 2 cycles
  • Rituximab — DRUG
    375mg/m2, max. 8 times
  • Cytarabine — DRUG
    3000mg/m2 die i.v., 2 days (max. 2 cycles)
  • Thiotepa — DRUG
    40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days
  • Carmustin — DRUG
    400mg/m2 i.v. for 1 day

Study Details

The purpose of this study is to determine whether combined chemotherapy \[rituximab plus high dosage methotrexate (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed by high dosage carmustin/thiotepa\] followed by peripheral blood stem cell transplantation is effective in the treatment of cerebral Non Hodgkin lymphoma \[PCNSL\].

Key Dates

First listed
Mar 31, 2008
Start date
Jan 31, 2007
Status verified
Nov 2009
Primary completion
May 31, 2013
Completion
Aug 31, 2013

Study Design

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

Arms

  • Experimental: A
    first diagnosis of PCNSL: combined chemotherapy with methotrexate
  • Experimental: B
    Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy

Primary Outcome Measure

Complete response rate [ Time Frame: 30 days after blood stem cell transplantation ]

Central Contacts