TY - JOUR AU - Collett, L. AU - Howard, D. R. AU - Munir, T. AU - McParland, L. AU - Oughton, J. B. AU - Rawstron, A. C. PY - 2017 DA - 2017// TI - Assessment of ibrutinib plus rituximab in front-line CLL (FLAIR trial): study protocol for a phase III randomised controlled trial JO - Trials. VL - 18 UR - https://doi.org/10.1186/s13063-017-2138-6 DO - 10.1186/s13063-017-2138-6 ID - Collett2017 ER - TY - JOUR AU - Blagden, S. P. AU - Billingham, L. AU - Brown, L. C. AU - Buckland, S. W. AU - Cooper, A. M. AU - Ellis, S. PY - 2020 DA - 2020// TI - Effective delivery of Complex Innovative Design (CID) cancer trials—a consensus statement JO - Br J Cancer VL - 122 UR - https://doi.org/10.1038/s41416-019-0653-9 DO - 10.1038/s41416-019-0653-9 ID - Blagden2020 ER - TY - JOUR AU - Woodcock, J. AU - LaVange, L. M. PY - 2017 DA - 2017// TI - Master protocols to study multiple therapies, multiple diseases, or both JO - N Engl J Med VL - 377 UR - https://doi.org/10.1056/NEJMra1510062 DO - 10.1056/NEJMra1510062 ID - Woodcock2017 ER - TY - JOUR AU - Berry, S. M. AU - Connor, J. T. AU - Lewis, R. J. PY - 2015 DA - 2015// TI - The platform trial: an efficient strategy for evaluating multiple treatments JO - JAMA. VL - 313 UR - https://doi.org/10.1001/jama.2015.2316 DO - 10.1001/jama.2015.2316 ID - Berry2015 ER - TY - JOUR AU - Angus, D. C. AU - Alexander, B. M. AU - Berry, S. AU - Buxton, M. AU - Lewis, R. AU - Paoloni, M. PY - 2019 DA - 2019// TI - Adaptive platform trials: definition, design, conduct and reporting considerations JO - Nat Rev Drug Discov VL - 18 UR - https://doi.org/10.1038/s41573-019-0034-3 DO - 10.1038/s41573-019-0034-3 ID - Angus2019 ER - TY - JOUR AU - Gallo, P. AU - Chuang-Stein, C. AU - Dragalin, V. AU - Gaydos, B. AU - Krams, M. AU - Pinheiro, J. PY - 2006 DA - 2006// TI - Adaptive designs in clinical drug development - an executive summary of the PhRMA Working Group JO - J Biopharm Stat VL - 16 UR - https://doi.org/10.1080/10543400600614742 DO - 10.1080/10543400600614742 ID - Gallo2006 ER - TY - JOUR AU - Hallek, M. AU - Fischer, K. AU - Fingerle-Rowson, G. AU - Fink, A. M. AU - Busch, R. AU - Mayer, J. PY - 2010 DA - 2010// TI - Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial JO - Lancet VL - 376 UR - https://doi.org/10.1016/S0140-6736(10)61381-5 DO - 10.1016/S0140-6736(10)61381-5 ID - Hallek2010 ER - TY - JOUR AU - Rawstron, A. C. AU - Fazi, C. AU - Agathangelidis, A. AU - Villamor, N. AU - Letestu, R. AU - Nomdedeu, J. PY - 2015 DA - 2015// TI - A complementary role of multiparameter flow cytometry and high-throughput sequencing for minimal residual disease detection in chronic lymphocytic leukemia: an European Research Initiative on CLL study JO - Leukemia. VL - 30 UR - https://doi.org/10.1038/leu.2015.313 DO - 10.1038/leu.2015.313 ID - Rawstron2015 ER - TY - STD TI - Bloodwise. Trials Acceleration Programme (TAP) https://bloodwise.org.uk/research/clinical-trials/tap: Bloodwise; 2018 [cited 2019 May]. UR - https://bloodwise.org.uk/research/clinical-trials/tap: ID - ref9 ER - TY - JOUR AU - Cohen, D. R. AU - Todd, S. AU - Gregory, W. M. AU - Brown, J. M. PY - 2015 DA - 2015// TI - Adding a treatment arm to an ongoing clinical trial: a review of methodology and practice JO - Trials. VL - 16 UR - https://doi.org/10.1186/s13063-015-0697-y DO - 10.1186/s13063-015-0697-y ID - Cohen2015 ER - TY - JOUR AU - Sydes, M. R. AU - Parmar, M. K. B. AU - Mason, M. D. AU - Clarke, N. W. AU - Amos, C. AU - Anderson, J. PY - 2012 DA - 2012// TI - Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial JO - Trials. VL - 13 UR - https://doi.org/10.1186/1745-6215-13-168 DO - 10.1186/1745-6215-13-168 ID - Sydes2012 ER - TY - JOUR AU - Schiavone, F. AU - Bathia, R. AU - Letchemanan, K. AU - Masters, L. AU - Amos, C. AU - Bara, A. PY - 2019 DA - 2019// TI - This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols JO - Trials. VL - 20 UR - https://doi.org/10.1186/s13063-019-3216-8 DO - 10.1186/s13063-019-3216-8 ID - Schiavone2019 ER - TY - JOUR AU - Hague, D. AU - Townsend, S. AU - Masters, L. AU - Rauchenberger, M. AU - Looy, N. AU - Diaz-Montana, C. PY - 2019 DA - 2019// TI - Changing platforms without stopping the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons JO - Trials. VL - 20 UR - https://doi.org/10.1186/s13063-019-3322-7 DO - 10.1186/s13063-019-3322-7 ID - Hague2019 ER - TY - JOUR AU - Morrell, L. AU - Hordern, J. AU - Brown, L. AU - Sydes, M. R. AU - Amos, C. L. AU - Kaplan, R. S. PY - 2019 DA - 2019// TI - Mind the gap? The platform trial as a working environment JO - Trials. VL - 20 UR - https://doi.org/10.1186/s13063-019-3377-5 DO - 10.1186/s13063-019-3377-5 ID - Morrell2019 ER - TY - JOUR AU - Ma, S. AU - Brander, D. M. AU - Seymour, J. F. AU - Kipps, T. J. AU - Barrientos, J. C. AU - Davids, M. S. PY - 2015 DA - 2015// TI - Deep and durable responses following venetoclax (ABT-199 / GDC-0199) combined with rituximab in patients with relapsed/refractory chronic lymphocytic leukemia: results from a phase 1b study JO - Blood. VL - 126 UR - https://doi.org/10.1182/blood.V126.23.830.830 DO - 10.1182/blood.V126.23.830.830 ID - Ma2015 ER - TY - JOUR AU - Portell, C. A. AU - Axelrod, M. AU - Brett, L. K. AU - Gordon, V. L. AU - Capaldo, B. AU - Xing, J. C. PY - 2014 DA - 2014// TI - Synergistic cytotoxicity of Ibrutinib and the BCL2 antagonist, ABT-199(GDC-0199) in mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL): molecular analysis reveals mechanisms of target interactions JO - Blood. VL - 124 UR - https://doi.org/10.1182/blood.V124.21.509.509 DO - 10.1182/blood.V124.21.509.509 ID - Portell2014 ER - TY - JOUR AU - Deng, J. AU - Isik, E. AU - Fernandes, S. M. AU - Brown, J. R. AU - Letai, A. AU - Davids, M. S. PY - 2015 DA - 2015// TI - Ibrutinib therapy increases BCL-2 dependence and enhances sensitivity to venetoclax in CLL JO - Blood. VL - 126 UR - https://doi.org/10.1182/blood.V126.23.490.490 DO - 10.1182/blood.V126.23.490.490 ID - Deng2015 ER - TY - JOUR AU - Hillmen, P. AU - Rawstron, A. C. AU - Brock, K. AU - Muñoz-Vicente, S. AU - Yates, F. J. AU - Bishop, R. PY - 2019 DA - 2019// TI - Ibrutinib plus venetoclax in relapsed/refractory chronic lymphocytic leukemia: the CLARITY Study JO - J Clin Oncol VL - 37 UR - https://doi.org/10.1200/JCO.19.00894 DO - 10.1200/JCO.19.00894 ID - Hillmen2019 ER - TY - JOUR AU - Burger, J. A. AU - Tedeschi, A. AU - Barr, P. M. AU - Robak, T. AU - Owen, C. AU - Ghia, P. PY - 2015 DA - 2015// TI - Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia JO - N Engl J Med VL - 373 UR - https://doi.org/10.1056/NEJMoa1509388 DO - 10.1056/NEJMoa1509388 ID - Burger2015 ER - TY - JOUR AU - O’Brien, P. C. AU - Fleming, T. R. PY - 1979 DA - 1979// TI - A multiple testing procedure for clinical trials JO - Biometrics. VL - 35 UR - https://doi.org/10.2307/2530245 DO - 10.2307/2530245 ID - O’Brien1979 ER - TY - JOUR AU - Burger, J. A. AU - Sivina, M. AU - Jain, N. AU - Kim, E. AU - Kadia, T. AU - Estrov, Z. PY - 2019 DA - 2019// TI - Randomized trial of ibrutinib vs ibrutinib plus rituximab in patients with chronic lymphocytic leukemia JO - Blood. VL - 133 UR - https://doi.org/10.1182/blood-2018-10-879429 DO - 10.1182/blood-2018-10-879429 ID - Burger2019 ER - TY - JOUR AU - Altman, D. G. PY - 2018 DA - 2018// TI - Avoiding bias in trials in which allocation ratio is varied JO - J R Soc Med VL - 111 UR - https://doi.org/10.1177/0141076818764320 DO - 10.1177/0141076818764320 ID - Altman2018 ER - TY - JOUR AU - Lee, K. M. AU - Wason, J. PY - 2020 DA - 2020// TI - Including non-concurrent control patients in the analysis of platform trials: is it worth it? JO - BMC Med Res Methodol VL - 20 UR - https://doi.org/10.1186/s12874-020-01043-6 DO - 10.1186/s12874-020-01043-6 ID - Lee2020 ER - TY - STD TI - CPMP (Committee for Proprietary Medicinal Products). Point to consider on multiplicity issues in clinical trials [PDF]. EMEA (European Medicines Agency); 2002 [Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003640.pdf]. Accessed 18 Dec 2020. UR - http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003640.pdf ID - ref24 ER - TY - JOUR AU - Howard, D. R. AU - Brown, J. M. AU - Todd, S. AU - Gregory, W. M. PY - 2018 DA - 2018// TI - Recommendations on multiple testing adjustment in multi-arm trials with a shared control group JO - Stat Methods Med Res VL - 27 UR - https://doi.org/10.1177/0962280216664759 DO - 10.1177/0962280216664759 ID - Howard2018 ER - TY - JOUR AU - Freidlin, B. AU - Korn, E. L. AU - Gray, R. AU - Martin, A. PY - 2008 DA - 2008// TI - Multi-arm clinical trials of new agents: some design considerations JO - Clin Cancer Res VL - 14 UR - https://doi.org/10.1158/1078-0432.CCR-08-0325 DO - 10.1158/1078-0432.CCR-08-0325 ID - Freidlin2008 ER - TY - STD TI - Howard DR. Analysis methods when adding an arm to an ongoing trial. Statistical issues when incorporating emerging therapies into ongoing randomised clinical trials. University of Leeds: White Rose eTheses Online, http://etheses.whiterose.ac.uk/22288/; 2018. Accessed 18 Dec 2020. UR - http://etheses.whiterose.ac.uk/22288/; ID - ref27 ER - TY - STD TI - Brown S, Thorpe H, Hawkins K, Brown J. Minimization—reducing predictability for multi-centre trials whilst retaining balance within centre. Stat Med. 2005;24(24):3715-27. https://doi.org/10.1002/sim.2391. ID - ref28 ER - TY - JOUR AU - Bennett, M. AU - Mander, A. P. PY - 2020 DA - 2020// TI - Designs for adding a treatment arm to an ongoing clinical trial JO - Trials. VL - 21 UR - https://doi.org/10.1186/s13063-020-4073-1 DO - 10.1186/s13063-020-4073-1 ID - Bennett2020 ER - TY - STD TI - Woyach JA, Ruppert AS, Heerema NA, Zhao W, Booth AM, Ding W, et al. Ibrutinib alone or in combination with rituximab produces superior progression free survival (PFS) compared with bendamustine plus rituximab in untreated older patients with chronic lymphocytic leukemia (CLL): results of Alliance North American Intergroup Study A041202. Blood. 2018;132(Supplement 1):6. https://doi.org/10.1182/blood-2018-99-116653. ID - ref30 ER - TY - STD TI - BBC News. Have they found a cure for our cancer? http://www.bbc.co.uk/news/stories-42920045: BBC; 2018 [updated 06 Feb 2018; cited 2019 May]. UR - http://www.bbc.co.uk/news/stories-42920045: ID - ref31 ER -