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

NCT01458730 | Completed Phase 2

• 1 other identifier: EudraCT No 2006-004772-12
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Lymphoma

Keywords

PCNSL; Immunochemotherapy; Intraspinal Depocyt; Maintenance temozolomide

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (2)

• response rate

  at completion of therapy

• neurotoxicity

  1-10 years after completion of therapy

Interventions

Immunochemotherapy DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Nordic Cancer Union: collaborator
• Roche Pharma AG: collaborator
• Mundipharma Pte Ltd.: collaborator
• Schering-Plough: collaborator

Study Sites (1)

Elisa Jacobsen Pulczynski

Aarhus, DK-8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 25480497 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: October 25, 2011
• Study Start: May 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: August 1, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

DK (1)