Data

Rituximab in Primary Central Nervous system Lymphoma. A randomized Dutch/Belgian Hemato-Oncology Cooperative Group (HOVON) / Australasian Leukaemia and Lymphoma Group (ALLG) intergroup study (NHL24)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 45 patients with newly diagnosed Primary Central Nervous System Lymphoma (PCNSL) assessing the addition of rituxumab vs standard chemotherapy Demographic data, diagnostic data, treatment data, outcome data
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Source Study

Funding

Commercial sector/Industry,Roche Products Pty Ltd

Scientific enquiries

Dr Dr Samar Issa

Brief Summary

Newly diagnosed PCNS lymphoma patients will be randomised to either 2 courses of MBVP or 2 courses of MBVP+Rituximab. All patients will undergo an MRI at the end of chemotherapy and be assessed for consolidation treatment with AraC, after which these patients will undergo another MRI to determine their eligibility or need for WBRT or not. The primary objective of the trial is event free survival.

Key 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 cerebrosp ....
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Key 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 equa ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    45

Min. age    18 Years

Max. age    70 Years

Sex    Both males and females

Condition category    primary central nervous system (CNS) lymphoma

Condition code    Cancer

Intervention

Intervention code Treatment: Drugs

2 courses (4 weeks each) of R-MBVP (Rituximab 375mg/m2 intravenously (i.v), course 1 days 0,7,14,21, course 2 days 0 and 14; methotrexate 3g/m2 iv days 1,15 for all courses; Teniposide 100mg/m2 i.v days 2,3 for all courses; BCNU (Carmustine) 100mg/m2 i.v day 4 for all courses; prednisolone 60mg/m2 orally or i.v days 1-5 for all courses) Following randomisation to MBVP or R-MBVP, patients will undergo an MRI. Patients with less than a complete response (CR) or partial response (PR) will be remove ....
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Comparison

Control group Active

2 courses (4 weeks each) of MBVP (methotrexate 3g/m2 iv days 1,15 for all courses; Teniposide 100mg/m2 i.v days 2,3 for all courses; BCNU (Carmustine) 100mg/m2 i.v day 4 for all courses; prednisolone 60mg/m2 orally or i.v days 1-5 for all courses) Following randomisation to MBVP or R-MBVP, patients will undergo an MRI. Patients with less than a complete response (CR) or partial response (PR) will be removed from study. Responding patients undergo consolidation with cytarabine (2 g/m2 i.v days 1, ....
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Outcomes

Outcome: Event-free survival of all patients defined as failure (relapse, no CR or CRu) or death from any cause.
Timepoint: at 1, 3 and 5 years

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au