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

August 3, 2022 updated by: University of Aarhus

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, DK-8000
        • Elisa Jacobsen Pulczynski

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: at completion of therapy
at completion of therapy
neurotoxicity
Time Frame: 1-10 years after completion of therapy
1-10 years after completion of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Mundipharma Pte Ltd.
Roche Pharma AG
Schering-Plough
Nordic Cancer Union

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

September 15, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (Estimate)

October 25, 2011

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT No 2006-004772-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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