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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Central Nervous System Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Immunochemotherapy

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No