Overview

This trial is active, not recruiting.

Condition central nervous system lymphoma
Treatment immunochemotherapy
Phase phase 2
Sponsor University of Aarhus
Collaborator Nordic Cancer Union
Start date May 2007
End date October 2010
Trial size 66 participants
Trial identifier NCT01458730, EudraCT No 2006-004772-12

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Overall survival
time frame:

Secondary Outcomes

Measure
response rate
time frame: at completion of therapy
neurotoxicity
time frame: 1-10 years after completion of therapy

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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.
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
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by University of Aarhus.