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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.


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Central Nervous System Lymphoma

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Trial Information

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.


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

EudraCT No 2006-004772-12

NCT ID:

NCT01458730

Start Date:

May 2007

Completion Date:

October 2020

Related Keywords:

  • Central Nervous System Lymphoma
  • PCNSL
  • Immunochemotherapy
  • Intraspinal Depocyt
  • Maintenance temozolomide
  • Lymphoma

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