- Oral presentation
- Open Access
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
© Maishman et al; licensee BioMed Central Ltd. 2013
- Published: 29 November 2013
- 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.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.