ALLG NHL24
ACTRN12610000908033
Treatment
Phase 3
Commercial sector/Industry,Roche Products Pty Ltd
Dr Dr Samar Issa
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.
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 .... Read more
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 .... Read more
No
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 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 .... Read more
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, .... Read more
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
yes
De-identified IPD data for all data collected during the trial
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any type of analysis Proposals will be assessed on a case-by-case basis