A novel adaptive trial design: randomised evaluation of molecular guided therapy for diffuse large b-cell lymphoma with bortezomib (REMODL-B) with two interim analyses to explore safety and efficacy
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KeywordsBortezomib Untreated Patient Sample Size Calculation Interim Analysis Randomise Phase
Retrospective molecular profiling of untreated Diffuse Large B-Cell Lymphoma (DLBCL) samples has recognised distinct sub-classifications of this disease, each with unique biological features and clinical outcomes.
To demonstrate superior clinical efficacy, of bortezomib in combination with rituximab and CHOP (RB-CHOP) versus R-CHOP for the treatment of previously untreated patients with DLBCL.
To assess whether the molecular phenotype determines benefit from the addition of bortezomib.
The first will be a safety analysis performed after the first 55 GCB RB-CHOP patients have been followed for 6 months. If 6 month PFS<80%, the GCB group will close.
The second will be for futility in the GCB group and performed after the first 73 GCB RB-CHOP patients have been followed for 1 year. If 1 year PFS<85%, the GCB group will close.
If the GCB group closes the trial will then be modified to a randomised Phase II trial in ABC patients and sample size calculations will be revised.
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