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

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