Main info

Identificatie:

HO105 NHL

Sponsor:

HOVON

Working group party:

Lymphoma

Age:

18-70

Stadium:

1st lijn

Echelon:

Level C-HIC

Included patients:

202

(of 202)

Active sites:

28

(of 29)

Title:

Rituximab in Primary Central Nervous system Lymphoma. A randomized HOVON / ALLG intergroup study

Timeline

News

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Not any more

Objectives:

Primary objective:

• To assess the effect of the addition of rituximab in a standard chemotherapy regime on EFS in newly diagnosed PCNSL

Secondary objective

• To evaluate the effect of the addition of rituximab to a standard chemotherapy regimen with respect to toxicity

Eligibility

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 μmol/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
• An active malignancy, that is expected to require treatment with chemotherapy within one year, or results in a life expectancy less than one year.

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals