Statistical Principles for Platform Trials

Authors: Cui, Xinping, Ouyang, Emily, Liu, Yi, Schneider, Jingjing, Tian, Hong, Wang, Bushi, Hsu, Jason C.

Subject Terms: Statistics - Methodology

Access URL: http://arxiv.org/abs/2302.12728

Peripheral neuropathy in the phase 3 ASPEN study of Bruton tyrosine kinase inhibitors for Waldenström macroglobulinemia

Authors: Heyman, Benjamin M. ^{1, ∗}, Opat, Stephen S. ², Wahlin, Björn E. ³, Dimopoulos, Meletios-Athanasios C. ⁴, Castillo, Jorge J. ⁵, Tedeschi, Alessandra ⁶, Tam, Constantine S. ^{7, 8}, Buske, Christian ⁹, Owen, Roger G. ¹⁰, Leblond, Véronique ¹¹, Trotman, Judith ¹², Barnes, Gisoo ¹³, Chan, Wai Y. ¹³, Schneider, Jingjing ¹³, Allewelt, Heather ¹³, Cohen, Aileen ¹³, Matous, Jeffrey V. ¹⁴

Source: In Blood Advances 25 February 2025 9(4):722-728

Biomarker analysis of the ASPEN study comparing zanubrutinib with ibrutinib for patients with Waldenström macroglobulinemia

Authors: Tam, Constantine S., Opat, Stephen, D'Sa, Shirley, Jurczak, Wojciech, Lee, Hui-Peng, Cull, Gavin, Owen, Roger G., Marlton, Paula, Wahlin, Björn E., García-Sanz, Ramón, McCarthy, Helen, Mulligan, Stephen, Tedeschi, Alessandra, Castillo, Jorge J., Czyż, Jarosław, Fernández De Larrea, Carlos, Belada, David, Libby, Edward, Matous, Jeffrey, Motta, Marina, Siddiqi, Tanya, Tani, Monica, Trněný, Marek, Minnema, Monique C., Buske, Christian, Leblond, Véronique, Treon, Steven P., Trotman, Judith, Wu, Binghao, Yu, Yiling, Shen, Zhirong, Chan, Wai Y., Schneider, Jingjing, Allewelt, Heather, Cohen, Aileen, Dimopoulos, Meletios A.

Source: In Blood Advances 9 April 2024 8(7):1639-1650

A robust latent CUSUM chart for monitoring customer attrition

Authors: Wu, Chunjie, Wang, Zhijun, MacEachern, Steven, Schneider, Jingjing

Source: Journal of applied statistics. 50(7):1477-1495

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100182505837.0x000001&indx=1&recIds=ETOCvdc_100182505837.0x000001

Zanubrutinib for the treatment of MYD88 wild-type Waldenström macroglobulinemia: a substudy of the phase 3 ASPEN trial

Authors: Dimopoulos, Meletios, Sanz, Ramon Garcia, Lee, Hui-Peng, Trneny, Marek, Varettoni, Marzia, Opat, Stephen, D'Sa, Shirley, Owen, Roger G., Cull, Gavin, Mulligan, Stephen, Czyz, Jaroslaw, Castillo, Jorge J., Motta, Marina, Siddiqi, Tanya, Gironella Mesa, Mercedes, Granell Gorrochategui, Miquel, Talaulikar, Dipti, Zinzani, Pier Luigi, Askari, Elham, Grosicki, Sebastian, Oriol, Albert, Rule, Simon, Kloczko, Janusz, Tedeschi, Alessandra, Buske, Christian, Leblond, Veronique, Trotman, Judith, Chan, Wai Y., Michel, Jan, Schneider, Jingjing, Tan, Ziwen, Cohen, Aileen, Huang, Jane, Tam, Constantine S.

Source: In Blood Advances 8 December 2020 4(23):6009-6018

A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study

Authors: Tam, Constantine S. ^{1, 1, 2, 3, 4}, Opat, Stephen ^{5, 6}, D'Sa, Shirley ⁷, Jurczak, Wojciech ⁸, Lee, Hui-Peng ⁹, Cull, Gavin ^{10, 11}, Owen, Roger G. ¹², Marlton, Paula ^{13, 14}, Wahlin, Björn E. ¹⁵, Sanz, Ramón Garcia ¹⁶, McCarthy, Helen ¹⁷, Mulligan, Stephen ¹⁸, Tedeschi, Alessandra ¹⁹, Castillo, Jorge J. ^{20, 21}, Czyz, Jaroslaw ^{22, 23}, Fernández de Larrea, Carlos ²⁴, Belada, David ²⁵, Libby, Edward ²⁶, Matous, Jeffrey V. ²⁷, Motta, Marina ²⁸, Siddiqi, Tanya ²⁹, Tani, Monica ³⁰, Trneny, Marek ³¹, Minnema, Monique C. ³², Buske, Christian ³³, Leblond, Veronique ³⁴, Trotman, Judith ^{35, 36}, Chan, Wai Y. ³⁷, Schneider, Jingjing ³⁷, Ro, Sunhee ³⁷, Cohen, Aileen ³⁷, Huang, Jane ³⁷, Dimopoulos, Meletios ³⁸

Source: In Blood 29 October 2020 136(18):2038-2050

Zanubrutinib (BGB-3111) plus obinutuzumab in patients with chronic lymphocytic leukemia and follicular lymphoma

Authors: Tam, Constantine S. ^*, Quach, Hang, Nicol, Andrew, Badoux, Xavier, Rose, Hannah, Prince, H. Miles, Leahy, Michael F., Eek, Richard, Wickham, Nicholas, Patil, Sushrut S., Huang, Jane, Prathikanti, Radha, Cohen, Aileen, Elstrom, Rebecca, Reed, William, Schneider, Jingjing, Flinn, Ian W.

Source: In Blood Advances 13 October 2020 4(19):4802-4811

Effect of evolocumab on lipoprotein apheresis requirement and lipid levels: Results of the randomized, controlled, open-label DE LAVAL study

Authors: Baum, Seth J., Sampietro, Tiziana, Datta, Dev, Moriarty, Patrick M., Knusel, Beat, Schneider, Jingjing, Somaratne, Ransi, Kurtz, Christopher, Hohenstein, Bernd

Source: In Journal of Clinical Lipidology November-December 2019 13(6):901-909

IBCL-117 ASPEN: Long-Term Follow-Up Results of a Phase 3 Randomized Trial of Zanubrutinib vs Ibrutinib in Patients With Waldenström Macroglobulinemia

Authors: Castillo, Jorge J. ¹, Tam, Constantine S. ², Garcia-Sanz, Ramon ³, Opat, Stephen ⁴, D'Sa, Shirley ⁵, Jurczak, Wojciech ⁶, Lee, Hui-Peng ⁷, Cull, Gavin ⁸, Owen, Roger G. ⁹, Marlton, Paula ¹⁰, Wahlin, Bjorn E. ¹¹, Tedeschi, Alessandra ¹², Siddiqi, Tanya ¹³, Buske, Christian ¹⁴, Leblond, Veronique ¹⁵, Chan, Wai Y. ¹⁶, Schneider, Jingjing ¹⁶, Cohen, Aileen ¹⁶, Dimopoulos, Meletios ¹⁷

Source: In Clinical Lymphoma, Myeloma and Leukemia October 2022 22 Supplement 2:S385-S385

Poster: IBCL-117 ASPEN: Long-Term Follow-Up Results of a Phase 3 Randomized Trial of Zanubrutinib vs Ibrutinib in Patients With Waldenström Macroglobulinemia

Authors: Castillo, Jorge J., Tam, Constantine S., Garcia-Sanz, Ramon, Opat, Stephen, D'Sa, Shirley, Jurczak, Wojciech, Lee, Hui-Peng, Cull, Gavin, Owen, Roger G., Marlton, Paula, Wahlin, Bjorn E., Tedeschi, Alessandra, Siddiqi, Tanya, Buske, Christian, Leblond, Veronique, Chan, Wai Y., Schneider, Jingjing, Cohen, Aileen, Dimopoulos, Meletios

Source: Clinical lymphoma, myeloma & leukemia. 22(S2):S172-S172

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100172883534.0x000001&indx=1&recIds=ETOCvdc_100172883534.0x000001

A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase Inhibitor (BTKi) Zanubrutinib in Patients with Waldenström Macroglobulinemia (WM)

Authors: Kingsley, Edwin C., Fabre, Shannon, Takai, Motohisa, Cohen, Aileen Cleary, Schneider, Jingjing, Li, Jessica, D'Olimpio, James

Source: In Blood 2 November 2023 142 Supplement 1:6171-6171

P-423 Partial response or better at 6 months is not a prognostic indicator of progression-free survival in Waldenström macroglobulinemia treated with zanubrutinib: a post hoc analysis of the ASPEN study

Authors: Castillo, Jorge, Tedeschi, Alessandra, Tam, Constantine, Buske, Christian, Owen, Roger, Leblond, Veronique, Opat, Stephen, Branagan, Andrew, Sarosiek, Shayna, Keudell, Gottfried von, Treon, Steven, Allewelt, Heather, Chan, Wai, Schneider, Jingjing, Dimopoulos, Meletios

Source: In Clinical Lymphoma, Myeloma and Leukemia September 2023 23 Supplement 2:S274-S274

P1679: HEALTH‐RELATED QUALITY OF LIFE IN PATIENTS (PTS) WITH WALDENSTRÖM MACROGLOBULINEMIA (WM) TREATED WITH ZANUBRUTINIB (ZANU) VS IBRUTINIB (IBR): RESULTS FROM THE PHASE 3 ASPEN TRIAL LONG‐TERM FOLLOW‐UP.

Authors: Tedeschi, Alessandra, Tam, Constantine, Owen, Roger, Buske, Christian, Leblond, Véronique, Dimopoulos, Meletios A., García‐Sanz, Ramón, Castillo, Jorge, Trotman, Judith, Treon, Steven, Yang, Keri, Tang, Boxiong, Allewelt, Heather, Patel, Sheel, Chan, Wai, Cohen, Aileen, Schneider, Jingjing Yan, Barnes, Gisoo

Source: HemaSphere; 2023 Supplement 3, Vol. 7, p1-2, 2p

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Biomarker analysis of the ASPEN study comparing zanubrutinib to ibrutinib in patients with Waldenström macroglobulinemia

Authors: Tam, Constantine S., Opat, Stephen, D'Sa, Shirley, Jurczak, Wojciech, Lee, Hui-Peng, Cull, Gavin, Owen, Roger G., Marlton, Paula, Wahlin, Bjorn E., García-Sanz, Ramón, McCarthy, Helen, Mulligan, Stephen, Tedeschi, Alessandra, Castillo, Jorge J., Czyż, Jaroslaw, De Larrea Rodriguez, Carlos Fernández, Belada, David, Libby, Edward, Matous, Jeffrey, Motta, Marina, Siddiqi, Tanya, Tani, Monica, Trněný, Marek, Minnema, Monique C., Buske, Christian, Leblond, Veronique, Treon, Steven P., Trotman, Judith, Wu, Binghao, Yu, Yiling, Shen, Zhirong, Chan, Wai Y., Schneider, Jingjing, Allewelt, Heather, Cohen, Aileen, Dimopoulos, Meletios

Source: Blood Advances; 20240101, Issue: Preprints

Design and rationale of the EBBINGHAUS trial: A phase 3, double-blind, placebo-controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid-lowering therapy-A cognitive study of patients enrolled in the FOURIER trial

Authors: Giugliano, Robert P., Mach, Francois, Zavitz, Kenton, Kurtz, Christopher, Schneider, Jingjing, Wang, Huei, Keech, Anthony, Pedersen, Terje R., Sabatine, Marc S., Sever, Peter S., Honarpour, Narimon, Wasserman, Scott M., Ott, Brian R.

Source: Clinical Cardiology; Feb2017, Vol. 40 Issue 2, p59-65, 7p