HOVON 105

Originele protocol

Inclusion criteria

  • Patients with a histologically confirmed diagnosis of CD20 positive DLBCL based upon a representative histology specimen of brain biopsy according to the WHO classification (see appendix A):
    OR
    Patients with a diagnosis of PCNSL based on MRI evidence of brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma
    AND
    Unequivocal morphological and/or immunophenotypical evidence of CSF
    CD20 + large cell lymphoma
    AND/OR Unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid
    OR
    Patients with unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid AND CSF but without a brain parenchymal lesion
  • Age 18-70 years inclusive
  • Performance status with or without administration of steroids WHO/ECOG 0-3 (see appendix D)
  • Written informed consent

Exclusion criteria

  • Evidence of systemic lymphoma
  • History of intolerance of exogenous protein administration
  • Severe cardiac dysfunction (NYHA classification III-IV, appendix G, or LVEF < 45%) Congestive heart failure or symptomatic coronary artery disease or cardiac arythmias not well controlled with medication
  • Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value)
  • Significant hepatic dysfunction (bilirubin or transaminase >= 2.5 x upper normal limit) at Screening.
  • Significant renal dysfunction (serum creatinine >= 150 micro?mol/l or clearance < 60 ml/min) at Screening
  • Presence of ‘third space fluid’, such as pleural effusion or ascites
  • Prior cranial radiotherapy
  • Active uncontrolled infection
  • HIV-positivity
  •  (EBV positive) post-transplant lymphoproliferative disorder
  • Untreated hepatitis B infection (inclusion is possible if adequate antiviral medication e.g. lamivudine or alternative is started and continued for the duration of the trial)
  • Positive pregnancy test in women of reproductive potential
  • Lactating women
  • Unable or unwilling to use adequate contraceptive methods (all men, pre-menopausal women) until 12 months after last chemotherapy treatment
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

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