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

Phase 3

Completed

• Conditions: Primary Central Nervous system Lymphoma; 10025320

• Registration Number: NL-OMON43562
• Lead Sponsor: HOVO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 130

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

-Evidence of systemic lymphoma
-History of intolerance of exogenous protein administration
-Severe cardiac dysfunction (NYHA classification III-IV, 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).
-Significant renal dysfunction (serum creatinine *150 umol/l or clearance < 60 ml/min
-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)
-Positive pregnancy test in women of reproductive potential
-Lactating women
-Unable or unwilling to use adequate contraceptive methods (all men, pre-menopausal women)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Event free survival </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Response rates after (R-) MBVP, after cytarabine and after completion of<br /><br>radiotherapy<br /><br>- Toxicity<br /><br>- Overall survival<br /><br>- Cognitive function and quality of life after treatment </p><br>