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Trial record 1 of 1 for:    NCT01458730
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Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma

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ClinicalTrials.gov Identifier: NCT01458730
Recruitment Status : Active, not recruiting
First Posted : October 25, 2011
Last Update Posted : November 16, 2012
Sponsor:
Collaborators:
Nordic Cancer Union
Roche Pharma AG
Mundipharma Pte Ltd.
Schering-Plough
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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.

Condition or disease Intervention/treatment Phase
Central Nervous System Lymphoma Drug: Immunochemotherapy Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : May 2007
Actual Primary Completion Date : October 2010
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Intervention Details:
  • Drug: Immunochemotherapy
    Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Iphosphamide, Vincristin, Vindesin, Temozolomide, Depocyte

Outcome Measures
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Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. response rate [ Time Frame: at completion of therapy ]
  2. neurotoxicity [ Time Frame: 1-10 years after completion of therapy ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458730


Locations
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Denmark
Elisa Jacobsen Pulczynski
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
Nordic Cancer Union
Roche Pharma AG
Mundipharma Pte Ltd.
Schering-Plough
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01458730     History of Changes
Other Study ID Numbers: EudraCT No 2006-004772-12
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: November 16, 2012
Last Verified: November 2012

Keywords provided by University of Aarhus:
PCNSL
Immunochemotherapy
Intraspinal Depocyt
Maintenance temozolomide

Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Temozolomide
Ifosfamide
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists