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

Primary Purpose

Central Nervous System Lymphoma

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Immunochemotherapy
Sponsored by
University of Aarhus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Nervous System Lymphoma focused on measuring PCNSL, Immunochemotherapy, Intraspinal Depocyt, Maintenance temozolomide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Elisa Jacobsen Pulczynski

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

response rate
neurotoxicity

Full Information

First Posted
September 15, 2011
Last Updated
August 3, 2022
Sponsor
University of Aarhus
Collaborators
Nordic Cancer Union, Roche Pharma AG, Mundipharma Pte Ltd., Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT01458730
Brief Title
Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
August 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Nordic Cancer Union, Roche Pharma AG, Mundipharma Pte Ltd., Schering-Plough

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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 To assess the long term outcome concerning neurotoxicity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Lymphoma
Keywords
PCNSL, Immunochemotherapy, Intraspinal Depocyt, Maintenance temozolomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Immunochemotherapy
Intervention Description
Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Iphosphamide, Vincristin, Vindesin, Temozolomide, Depocyte
Primary Outcome Measure Information:
Title
Overall survival
Secondary Outcome Measure Information:
Title
response rate
Time Frame
at completion of therapy
Title
neurotoxicity
Time Frame
1-10 years after completion of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Elisa Jacobsen Pulczynski
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25480497
Citation
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.
Results Reference
derived

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

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