Central Nervous System Lymphoma Clinical Trial
Official title:
Immunochemotherapy in Primary Central Nervous System Lymphoma With Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Ifosfamide, Vincristine, Vindesine, Temozolomide and DepoCyte Induction Followed by Maintenance Treatment in Elderly Patients With Temozolomide.
Verified date | August 2022 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | August 2022 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Elisa Jacobsen Pulczynski | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Mundipharma Pte Ltd., Nordic Cancer Union, Roche Pharma AG, Schering-Plough |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | |||
Secondary | response rate | at completion of therapy | ||
Secondary | neurotoxicity | 1-10 years after completion of therapy |
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