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CompletedNCT01458730Updated Aug 4, 2022

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

A Phase 2 interventional study of Immunochemotherapy in Central Nervous System Lymphoma, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by University of Aarhus · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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
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Conditions studied

  • Central Nervous System Lymphoma

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Keywords

  • PCNSL
  • Immunochemotherapy
  • Intraspinal Depocyt
  • Maintenance temozolomide
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 66 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

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Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
66 participants (actual)

Interventions

  • DrugImmunochemotherapy

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

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What researchers measure

Primary outcomes

  1. Overall survival

Secondary outcomes

  1. response rate

    Time frame: at completion of therapy

  2. neurotoxicity

    Time frame: 1-10 years after completion of therapy

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Study locations

1 site
  • Elisa Jacobsen Pulczynski
    Aarhus, DK-8000, Denmark
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References and documents

Publications

  • Pulczynski EJ, Kuittinen O, Erlanson M, Hagberg H, Fossa A, Eriksson M, Nordstrom M, Ostenstad B, Fluge O, Leppa S, Fiirgaard B, Bersvendsen H, Fagerli UM. Successful change of treatment strategy in elderly patients with primary central nervous system lymphoma by de-escalating induction and introducing temozolomide maintenance: results from a phase II study by the Nordic Lymphoma Group. Haematologica. 2015 Apr;100(4):534-40. doi: 10.3324/haematol.2014.108472. Epub 2014 Dec 5. PubMed 25480497 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01458730
Lead sponsor
University of Aarhus
Collaborators
Nordic Cancer Union, Roche Pharma AG, Mundipharma Pte Ltd., Schering-Plough
Responsible party
Sponsor
First posted
Oct 25, 2011
Start date
May 2007
Primary completion
Oct 2010
Completion
Aug 2022
Last update
Aug 4, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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