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

Rituximab in Primary Central Nervous system Lymphoma. A randomized HOVON / ALLG intergroup study - HOVON 105 PCNSL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43562
Enrollment
130
Registered
2009-10-20
Start date
2010-07-23
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Central Nervous system Lymphoma

Interventions

All patients will be treated with MBVP chemotherapy followed by cytarabine and, in patients up to 60 years of age, whole brain radiotherapy. In addition, patients randomized to the investigational a

Sponsors

HOVON
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 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 0 * 3 -Written informed consent

Exclusion criteria

Exclusion criteria: -Evidence of systemic lymphoma -History of intolerance of exogenous protein administration -Severe cardiac dysfunction (NYHA classification III-IV, or LVEF

Design outcomes

Primary

MeasureTime frame
- Event free survival

Secondary

MeasureTime frame
- Response rates after (R-) MBVP, after cytarabine and after completion of radiotherapy - Toxicity - Overall survival - Cognitive function and quality of life after treatment

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)