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

Central Nervous System Lymphoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458730
• Other study ID #: EudraCT No 2006-004772-12
• Status: Completed
• Phase: Phase 2
• Start date: May 2007
• Est. completion date: August 2022

Study information

• Verified date: August 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2022
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Lymphoma
• Lymphoma

Intervention

Drug:
• Immunochemotherapy
Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Iphosphamide, Vincristin, Vindesin, Temozolomide, Depocyte

Locations

Country	Name	City	State
Denmark	Elisa Jacobsen Pulczynski	Aarhus

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Mundipharma Pte Ltd., Nordic Cancer Union, Roche Pharma AG, Schering-Plough

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	response rate		at completion of therapy
Secondary	neurotoxicity		1-10 years after completion of therapy