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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01458730
Other study ID # EudraCT No 2006-004772-12
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2007
Est. completion date August 2022

Study information

Verified date August 2022
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 by temozolomide maintenance treatment in newly diagnosed primary central nervous system lymphoma 2. To assess the long term outcome concerning neurotoxicity


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Immunochemotherapy
Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Iphosphamide, Vincristin, Vindesin, Temozolomide, Depocyte

Locations

Country Name City State
Denmark Elisa Jacobsen Pulczynski Aarhus

Sponsors (5)

Lead Sponsor Collaborator
University of Aarhus Mundipharma Pte Ltd., Nordic Cancer Union, Roche Pharma AG, Schering-Plough

Country where clinical trial is conducted

Denmark, 

Outcome

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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