Status:
COMPLETED
Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Nordic Cancer Union
Roche Pharma AG
Conditions:
Central Nervous System Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to test the efficacy and tolerability of a multiagent chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma in the brain.
Detailed Description
The objective of the study is 1. To investigate the efficacy and safety of a high-dose methotrexate-based induction polychemotherapy regimen combined with Rituximab and intraspinal DepoCyte followed ...
Eligibility Criteria
Inclusion
- Pathologically verified primary central nervous system lymphoma No prior PCNSL treatment.
- Patients treated with steroids alone are eligible
- No signs of lymphoma outside the CNS
- ECOG performance status 0-4
- Age \> 17 and \< 76 years
- Written informed consent from the patient or guardian
Exclusion
- Cardiac failure \> 3
- Pregnancy or lactation. Women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication
- Previous malignancy unless disease free for at least five years
- Active infection.
- Regarding tuberculosis, patients at risk should be tested for latent TB according local practice at each treating centre.
- Positive HIV status
- Organ transplantation
- Serious psychiatric illness
- Prior radiotherapy to the brain
- Concomitant anti-inflammatory medication that cannot be discontinued
- Creatinine clearance \< 60 ml/minute calculated by Cockcroft and Gault formula
- Peripheral blood count with granulocytes \<1.5 x 109L or platelets \< 100 x 109L
- Serum bilirubin \>1.5 times or ASAT and alkaline phosphatase \>2 times upper limits of normal.
- Known anaphylaxis or IgE-mediated hypersensitivity to murine protein or any component of Rituximab excludes patients from Rituximab treatment, but not from the remaining part of the study
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01458730
Start Date
May 1 2007
End Date
August 1 2022
Last Update
August 4 2022
Active Locations (1)
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1
Elisa Jacobsen Pulczynski
Aarhus, Denmark, DK-8000