Clinical trial NCT01458730: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Central Nervous System Lymphoma
Keywords: PCNSL
Immunochemotherapy
Intraspinal Depocyt
Maintenance temozolomide
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Nordic Cancer Union
name: Roche Pharma AG
name: Mundipharma Pte Ltd.
name: Schering-Plough
First posted: 2011-10-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

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

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: response rate
timeFrame: at completion of therapy
measure: neurotoxicity
timeFrame: 1-10 years after completion of therapy
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Elisa Jacobsen Pulczynski
Study officials:
References:
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.