Rituximab in Primary Central Nervous system Lymphoma.A randomized Dutch/Belgian Hemato-Oncology Cooperative Group (HOVON) / Australasian Leukaemia and Lymphoma Group (ALLG) intergroup study

Phase 3

Active, not recruiting

• Conditions: primary central nervous system (CNS) lymphoma; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

• Registration Number: ACTRN12610000908033
• Lead Sponsor: HOVO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-25
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Patients with a histologically confirmed diagnosis of CD20 positive diffuse large B cell lymphoma (DLBCL) based upon a representative histology specimen of brain biopsy according to the world health organisation (WHO) classification;
OR
2. Patients with a diagnosis of PCNSL based on magnetic resonance imaging (MRI) evidence of brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma;
AND
3. Unequivocal morphological and/or immunophenotypical evidence of cerebrospinal fluid (CSF) CD20 + large cell lymphoma;
4. AND/OR Unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid;
OR
5. Patients with unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid AND CSF but without a brain parenchymal lesion;
6. Age 18-70 years inclusive;
7. Performance status with or without administration of steroids WHO/Eastern cooperative group (ECOG) 0-3;
8. Written informed consent.

Exclusion Criteria

1. Evidence of systemic lymphoma;
2. History of intolerance of exogenous protein administration;
3. Severe cardiac dysfunction (NYHA classification III-IV, , or Left Ventricular Ejection Fraction < 45%) Congestive heart failure or symptomatic coronary artery disease or cardiac arythmias not well controlled with medication ;
4. Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value);
5. Significant hepatic dysfunction (bilirubin or transaminase greater or equal to 2.5 x upper normal limit) at Screening;
6. Significant renal dysfunction (serum creatinine greater than or equal to 150 micromol/l or clearance < 60 ml/min) at Screening;
7. Presence of third space fluid, such as pleural effusion or ascites;
8. Prior cranial radiotherapy;
9. Active uncontrolled infection;
10. Human immunodeficiency virus (HIV)-positivity;
11. Epstein barr virus (EBV) positive post-transplant lymphoproliferative disorder;
12. 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);
13. Positive pregnancy test in women of reproductive potential;
14. Lactating women;
15. Unable or unwilling to use adequate contraceptive methods (all men, pre-menopausal women) until 12 months after last chemotherapy treatment;
16. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival of all patients defined as failure (relapse, no CR or CRu) or death from any cause.[ at 1, 3 and 5 years]

Secondary Outcome Measures

Name	Time	Method
Response rates by MRI[ after (R-)MBVP, after high dose cytarabine and after completion of radiotherapy]