Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma

Phase 2

Completed

• Conditions: Central Nervous System Lymphoma

• Registration Number: NCT01458730
• Lead Sponsor: University of Aarhus

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 by temozolomide maintenance treatment in newly diagnosed primary central nervous system lymphoma

2. To assess the long term outcome concerning neurotoxicity

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2010-10
• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Status Verified: 2022-08
• Study Completion: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
response rate	at completion of therapy
neurotoxicity	1-10 years after completion of therapy

Trial Locations

Locations (1)

Elisa Jacobsen Pulczynski; 🇩🇰 Aarhus, Denmark