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2. Integrated safety analysis of umbralisib, a dual PI3Kδ/CK1ε inhibitor, in relapsed/refractory lymphoid malignancies

Author

Davids, Matthew S., O'Connor, Owen A., Jurczak, Wojciech, Samaniego, Felipe, Fenske, Timothy S., Zinzani, Pier Luigi, Patel, Manish R., Ghosh, Nilanjan, Cheson, Bruce D., Derenzini, Enrico, Brander, Danielle M., Reeves, James A., Knopińska-Posłuszny, Wanda, Allan, John N., Phillips, Tycel, Caimi, Paolo F., Lech-Maranda, Ewa, Burke, John M., Agajanian, Richy, Pettengell, Ruth, Leslie, Lori A., Cheah, Chan Y., Fonseca, Gustavo, Essell, James, Chavez, Julio C., Pagel, John M., Sharman, Jeff P., Hsu, Yanzhi, Miskin, Hari P., Sportelli, Peter, Weiss, Michael S., and Flinn, Ian W.

Published
2021
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3. Ublituximab plus ibrutinib versus ibrutinib alone for patients with relapsed or refractory high-risk chronic lymphocytic leukaemia (GENUINE): a phase 3, multicentre, open-label, randomised trial

Author

Sharman, Jeff P, Brander, Danielle M, Mato, Anthony R, Ghosh, Nilanjan, Schuster, Stephen J, Kambhampati, Suman, Burke, John M, Lansigan, Frederick, Schreeder, Marshall T, Lunin, Scott D, Zweibach, Alexander, Shtivelband, Mikhail, Travis, Patrick M, Chandler, Jason C, Kolibaba, Kathryn S, Sportelli, Peter, Miskin, Hari P, Weiss, Michael S, and Flinn, Ian W

Published
2021
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4. Editor's Note: Targeting Akt and Heat Shock Protein 90 Produces Synergistic Multiple Myeloma Cell Cytotoxicity in the Bone Marrow Microenvironment

Author

Huston, Alissa, primary, Leleu, Xavier, additional, Jia, Xiaoying, additional, Moreau, Anne-Sophie, additional, Ngo, Hai T., additional, Runnels, Judith, additional, Anderson, Judy, additional, Alsayed, Yazan, additional, Roccaro, Aldo, additional, Vallet, Sonia, additional, Hatjiharissi, Evdoxia, additional, Tai, Yu-Tsu, additional, Sportelli, Peter, additional, Munshi, Nikhil, additional, Richardson, Paul, additional, Hideshima, Teru, additional, Roodman, David G., additional, Anderson, Kenneth C., additional, and Ghobrial, Irene M., additional

Published
2024
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6. Tolerability and activity of ublituximab, umbralisib, and ibrutinib in patients with chronic lymphocytic leukaemia and non-Hodgkin lymphoma: a phase 1 dose escalation and expansion trial

Author

Nastoupil, Loretta J, Lunning, Matthew A, Vose, Julie M, Schreeder, Marshall T, Siddiqi, Tanya, Flowers, Christopher R, Cohen, Jonathon B, Burger, Jan A, Wierda, William G, O'Brien, Susan, Sportelli, Peter, Miskin, Hari P, Purdom, Michelle A, Weiss, Michael S, and Fowler, Nathan H

Published
2019
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7. Umbralisib in combination with ibrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia or mantle cell lymphoma: a multicentre phase 1–1b study

Author

Davids, Matthew S, Kim, Haesook T, Nicotra, Alyssa, Savell, Alexandra, Francoeur, Karen, Hellman, Jeffrey M, Bazemore, Josie, Miskin, Hari P, Sportelli, Peter, Stampleman, Laura, Maegawa, Rodrigo, Rueter, Jens, Boruchov, Adam M, Arnason, Jon E, Jacobson, Caron A, Jacobsen, Eric D, Fisher, David C, and Brown, Jennifer R

Published
2019
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8. Supplementary Data from Adding Umbralisib and Ublituximab (U2) to Ibrutinib in Patients with CLL: A Phase II Study of an MRD-Driven Approach

Author

Roeker, Lindsey E., primary, Feldman, Tatyana A., primary, Soumerai, Jacob D., primary, Falco, Victoria, primary, Panton, Gail, primary, Dorsey, Colleen, primary, Zelenetz, Andrew D., primary, Falchi, Lorenzo, primary, Park, Jae H., primary, Straus, David J., primary, Pena Velasquez, Camila, primary, Lebowitz, Sonia, primary, Fox, Yehudit, primary, Battiato, Kristen, primary, Laudati, Carissa, primary, Thompson, Meghan C., primary, McCarthy, Elizabeth, primary, Kdiry, Sabrina, primary, Martignetti, Rosalba, primary, Turpuseema, Teja, primary, Purdom, Michelle, primary, Paskalis, Dana, primary, Miskin, Hari P., primary, Sportelli, Peter, primary, Leslie, Lori A., primary, and Mato, Anthony R., primary

Published
2023
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9. Data from Adding Umbralisib and Ublituximab (U2) to Ibrutinib in Patients with CLL: A Phase II Study of an MRD-Driven Approach

Author

Roeker, Lindsey E., primary, Feldman, Tatyana A., primary, Soumerai, Jacob D., primary, Falco, Victoria, primary, Panton, Gail, primary, Dorsey, Colleen, primary, Zelenetz, Andrew D., primary, Falchi, Lorenzo, primary, Park, Jae H., primary, Straus, David J., primary, Pena Velasquez, Camila, primary, Lebowitz, Sonia, primary, Fox, Yehudit, primary, Battiato, Kristen, primary, Laudati, Carissa, primary, Thompson, Meghan C., primary, McCarthy, Elizabeth, primary, Kdiry, Sabrina, primary, Martignetti, Rosalba, primary, Turpuseema, Teja, primary, Purdom, Michelle, primary, Paskalis, Dana, primary, Miskin, Hari P., primary, Sportelli, Peter, primary, Leslie, Lori A., primary, and Mato, Anthony R., primary

Published
2023
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10. Data from Dual Inhibition of Akt/Mammalian Target of Rapamycin Pathway by Nanoparticle Albumin-Bound–Rapamycin and Perifosine Induces Antitumor Activity in Multiple Myeloma

Author

Cirstea, Diana, primary, Hideshima, Teru, primary, Rodig, Scott, primary, Santo, Loredana, primary, Pozzi, Samantha, primary, Vallet, Sonia, primary, Ikeda, Hiroshi, primary, Perrone, Giulia, primary, Gorgun, Gullu, primary, Patel, Kishan, primary, Desai, Neil, primary, Sportelli, Peter, primary, Kapoor, Shweta, primary, Vali, Shireen, primary, Mukherjee, Siddhartha, primary, Munshi, Nikhil C., primary, Anderson, Kenneth C., primary, and Raje, Noopur, primary

Published
2023
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11. Supplementary Data from Dual Inhibition of Akt/Mammalian Target of Rapamycin Pathway by Nanoparticle Albumin-Bound–Rapamycin and Perifosine Induces Antitumor Activity in Multiple Myeloma

Author

Cirstea, Diana, primary, Hideshima, Teru, primary, Rodig, Scott, primary, Santo, Loredana, primary, Pozzi, Samantha, primary, Vallet, Sonia, primary, Ikeda, Hiroshi, primary, Perrone, Giulia, primary, Gorgun, Gullu, primary, Patel, Kishan, primary, Desai, Neil, primary, Sportelli, Peter, primary, Kapoor, Shweta, primary, Vali, Shireen, primary, Mukherjee, Siddhartha, primary, Munshi, Nikhil C., primary, Anderson, Kenneth C., primary, and Raje, Noopur, primary

Published
2023
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12. Phase 2 trial of umbralisib, ublituximab, and venetoclax in patients with relapsed/refractory mantle cell lymphoma.

Author

Wallace, Danielle S., Rowland, Chris, Hill, Brian T., Baran, Andrea M., Casulo, Carla, Reagan, Patrick M., Winter, Allison, Karmali, Reem, Winter, Jane N., Gordon, Leo I., Bui, Andrew, Sportelli, Peter, Miskin, Hari P., Weiss, Michael S., Friedberg, Jonathan W., Ma, Shuo, and Barr, Paul M.

Subjects
BRUTON tyrosine kinase, VENETOCLAX, MANTLE cell lymphoma
Abstract

Patients with mantle cell lymphoma require treatment options following BTK inhibition, as evidenced by the 14.6 months median OS rate from initiation of BTK inhibitor in the recently published SCHOLAR-2 analysis [[11]]. Nine patients were refractory to prior therapy, 9 had previously received a BTK inhibitor (BTKi) including 7 who were refractory to BTKi and there were 3 who had progressive lymphoma following chimeric antigen receptor T-cell (CAR-T) therapy. Novel agents such as the Bruton's tyrosine kinase (BTK) inhibitors have improved outcomes for patients with mantle cell lymphoma (MCL) and continue to change treatment paradigms [[1]]. [Extracted from the article]

Published
2023
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15. Adding Umbralisib and Ublituximab (U2) to Ibrutinib in Patients with CLL: A Phase 2 Study of an MRD-driven Approach

Author

Roeker, Lindsey E., Feldman, Tatyana A., Soumerai, Jacob D., Falco, Victoria, Panton, Gail, Dorsey, Colleen, Zelenetz, Andrew D., Falchi, Lorenzo, Park, Jae H., Straus, David J., Velasquez, Camila Pena, Lebowitz, Sonia, Fox, Yehudit, Battiato, Kristen, Laudati, Carissa, Thompson, Meghan C., McCarthy, Elizabeth, Kdiry, Sabrina, Martignetti, Rosalba, Turpuseema, Teja, Purdom, Michelle, Paskalis, Dana, Miskin, Hari P., Sportelli, Peter, Leslie, Lori A., and Mato, Anthony R.

Subjects
Neoplasm, Residual, Piperidines, Adenine, Antineoplastic Combined Chemotherapy Protocols, Antibodies, Monoclonal, Humans, Heterocyclic Compounds, 4 or More Rings, Leukemia, Lymphocytic, Chronic, B-Cell, Article
Abstract

Ibrutinib has transformed the management of chronic lymphocytic leukemia (CLL), though its use is limited by toxicity and resistance. In this study, we utilized an "add on" approach for patients who had been treated with ibrutinib in the front-line or relapsed/refractory settings with detectable MRD. Umbralisib and ublituximab (U2) were added on to ibrutinib, patients were treated until achieving undetectable-MRD (U-MRD), and then they entered a period of treatment-free observation (TFO).Patients were eligible if they received ibrutinib in any line of therapy for at least 6 months and had detectable MRD (flow cytometry,1 cell in 10-4 cutoff for U-MRD). U2 was added to ibrutinib, and patients were monitored serially for MRD. Once U-MRD was achieved or a total of 24 cycles were administered, patients entered a period of TFO. The primary study objective was rate of U-MRD. Secondary endpoints included safety and durability of clinical benefit after treatment discontinuation.Twenty-eight patients were enrolled of whom 27 were evaluable for efficacy. Patients received ibrutinib for a median of 21 months (range 7-67) prior to study enrollment. Fourteen patients (52%) have achieved U-MRD per protocol whereas 78% had at least one U-MRD evaluation. Seventeen patients (63%) have entered TFO after a median of 6.4 months on triplet therapy. Progression-free survival at 12 months was estimated at 95%. Grade ≥3 adverse events were hypertension 7%, diarrhea 4%, and increased ALT/AST 4%.This triplet approach utilizes the addition of U2 to ibrutinib as an MRD-driven time-limited therapy. This therapy was well tolerated and effective. TFO following this therapy appears durable in ongoing follow-up.

Published
2022

16. Adding Umbralisib and Ublituximab (U2) to Ibrutinib in Patients with CLL: A Phase II Study of an MRD-Driven Approach

Author

Roeker, Lindsey E., primary, Feldman, Tatyana A., additional, Soumerai, Jacob D., additional, Falco, Victoria, additional, Panton, Gail, additional, Dorsey, Colleen, additional, Zelenetz, Andrew D., additional, Falchi, Lorenzo, additional, Park, Jae H., additional, Straus, David J., additional, Pena Velasquez, Camila, additional, Lebowitz, Sonia, additional, Fox, Yehudit, additional, Battiato, Kristen, additional, Laudati, Carissa, additional, Thompson, Meghan C., additional, McCarthy, Elizabeth, additional, Kdiry, Sabrina, additional, Martignetti, Rosalba, additional, Turpuseema, Teja, additional, Purdom, Michelle, additional, Paskalis, Dana, additional, Miskin, Hari P., additional, Sportelli, Peter, additional, Leslie, Lori A., additional, and Mato, Anthony R., additional

Published
2022
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17. Ublituximab (TG‐1101), a novel glycoengineered anti‐CD20 antibody, in combination with ibrutinib is safe and highly active in patients with relapsed and/or refractory chronic lymphocytic leukaemia: results of a phase 2 trial

Author

Sharman, Jeff P., Farber, Charles M., Mahadevan, Daruka, Schreeder, Marshall T., Brooks, Heather D., Kolibaba, Kathryn S., Fanning, Suzanne, Klein, Leonard, Greenwald, Daniel R., Sportelli, Peter, Miskin, Hari P., Weiss, Michael S., and Burke, John M.

Published
2017
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18. The Combination of Umbralisib Plus Ublituximab Is Active in Patients with Relapsed or Refractory Marginal Zone Lymphoma (MZL): Results from the Phase 2 Global Unity-NHL Trial

Author

Chavez, Julio C., primary, Goldschmidt, Neta, additional, Samaniego, Felipe, additional, Wrobel, Tomasz, additional, Cavallo, Federica, additional, Fonseca, Gustavo, additional, Yoon, Sung-Soo, additional, Drgona, Lubos, additional, Hawkes, Eliza, additional, Levi, Itai, additional, Miskin, Hari P., additional, Sportelli, Peter, additional, O'Connor, Owen A., additional, Fowler, Nathan H., additional, and Zinzani, Pier Luigi, additional

Published
2021
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19. Favorable Outcomes for Patients Treated with U2 with Co-Morbidities or Concomitant Medications: A Retrospective Analysis of Unity-CLL Phase 3 Trial

Author

Pinilla Ibarz, Javier, primary, Jurczak, Wojciech, additional, Kambhampati, Suman, additional, Lech Maranda, Ewa, additional, Wróbel, Tomasz, additional, Sharman, Jeff P., additional, Zafar, Syed F., additional, Hoffmann, Marc, additional, Huntington, Scott F., additional, Jacobs, Ryan, additional, Bairey, Osnat, additional, Rowland, Chris, additional, Miskin, Hari P., additional, Sportelli, Peter, additional, Weiss, Michael S., additional, O'Connor, Owen A., additional, and Flinn, Ian W., additional

Published
2021
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20. Efficacy and Safety of Ublituximab in Combination with Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia (CLL) By Treatment Status: A Sub-Analysis of the Phase 3 Unity-CLL Study

Author

Jacobs, Ryan, primary, Jurczak, Wojciech, additional, Flinn, Ian W., additional, Grosicki, Sebastian, additional, Giannopoulos, Krzysztof, additional, Wróbel, Tomasz, additional, Zafar, Syed F., additional, Cultrera, Jennifer L., additional, Kambhampati, Suman, additional, Danilov, Alexey V., additional, Burke, John M., additional, Goldschmidt, Jerome, additional, Beach, Douglas F., additional, Huntington, Scott F., additional, Pinilla Ibarz, Javier, additional, Sharman, Jeff P., additional, Siddiqi, Tanya, additional, Brander, Danielle M., additional, Shadman, Mazyar, additional, Pagel, John M., additional, Dlugosz-Danecka, Monika, additional, Ghosh, Nilanjan, additional, Kolibaba, Kathryn S., additional, Sportelli, Peter, additional, Miskin, Hari P., additional, O'Connor, Owen A., additional, Weiss, Michael S., additional, and Gribben, John G., additional

Published
2021
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21. A Phase 2 Study Evaluating the Addition of Ublituximab and Umbralisib (U2) to Ibrutinib in Patients with Chronic Lymphocytic Leukemia (CLL): A Minimal Residual Disease (MRD)-Driven, Time-Limited Approach

Author

Roeker, Lindsey E., primary, Leslie, Lori A., additional, Soumerai, Jake D., additional, Falco, Victoria, additional, Panton, Gail, additional, Zelenetz, Andrew D., additional, Falchi, Lorenzo, additional, Park, Jae H, additional, Pena-Velasquez, Camila, additional, Lebowitz, Sonia, additional, Battiato, Kristen, additional, Laudati, Carissa, additional, Thompson, Meghan C., additional, Straus, David J., additional, Fox, Yehudit, additional, McCarthy, Elizabeth, additional, Kdiry, Sabrina, additional, Martignetti, Rosalba, additional, Miskin, Hari P., additional, Sportelli, Peter, additional, and Mato, Anthony R., additional

Published
2021
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22. Efficacy and Safety of Umbralisib, Ublituximab (U2), and U2 Plus Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Author

Burke, John M., primary, Fonseca, Gustavo, additional, Jurczak, Wojciech, additional, Melear, Jason, additional, Islas-Ohlmayer, Miguel, additional, Reeves, James A, additional, Venugopal, Parameswaran, additional, Wróbel, Tomasz, additional, Stevens, Don, additional, Pagel, John M., additional, Goldschmidt, Jerome, additional, Miskin, Hari P., additional, Sportelli, Peter, additional, O'Connor, Owen A., additional, and Ghosh, Nilanjan, additional

Published
2021
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23. IBCL-203: Umbralisib, a PI3Kδ/CK1ε Dual Inhibitor Demonstrates Marked Clinical Activity in Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma (iNHL): Results from the Phase 2 Global UNITY-NHL Trial

Author

Ghosh, Nilanjan, primary, Zinzani, Pier Luigi, additional, Samaniego, Felipe, additional, Jurczak, Wojciech, additional, Derenzini, Enrico, additional, Reeves, James A., additional, Knopinska-Posluszny, Wanda, additional, Cheah, Chan Y., additional, Phillips, Tycel, additional, Lech-Maranda, Ewa, additional, Cheson, Bruce, additional, Calmi, Paolo, additional, Grosicki, Sebastian, additional, Leslie, Lori A., additional, Chavez, Julio C., additional, Fonseca, Gustavo, additional, Babu, Sunil, additional, Hodson, Daniel J., additional, Shao, Spencer H., additional, Burke, John M., additional, Sharman, Jeff P., additional, Law, Jennie Y., additional, Pagel, John M., additional, Miskin, Hari P., additional, Sportelli, Peter, additional, O’Connor, Owen A., additional, Weiss, Michael S., additional, and Fowler, Nathan H., additional

Published
2021
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24. Poster: IBCL-203: Umbralisib, a PI3Kδ/CK1ε Dual Inhibitor Demonstrates Marked Clinical Activity in Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma (iNHL): Results from the Phase 2 Global UNITY-NHL Trial

Author

Ghosh, Nilanjan, primary, Zinzani, Pier Luigi, additional, Samaniego, Felipe, additional, Jurczak, Wojciech, additional, Derenzini, Enrico, additional, Reeves, James A., additional, Knopinska-Posluszny, Wanda, additional, Cheah, Chan Y., additional, Phillips, Tycel, additional, Lech-Maranda, Ewa, additional, Cheson, Bruce, additional, Caimi, Paolo, additional, Grosicki, Sebastian, additional, Leslie, Lori A., additional, Chavez, Julio C., additional, Fonseca, Gustavo, additional, Babu, Sunil, additional, Hodson, Daniel J., additional, Shao, Spencer H., additional, Burke, John M., additional, Sharman, Jeff P., additional, Law, Jennie Y., additional, Pagel, John M., additional, Miskin, Hari P., additional, Sportelli, Peter, additional, O’Connor, Owen A., additional, Weiss, Michael S., additional, and Fowler, Nathan H., additional

Published
2021
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25. Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 Unity-CLL Study

Author

Gribben, John G., Jurczak, Wojciech, Jacobs, Ryan W., Grosicki, Sebastian, Giannopoulos, Krzysztof, Wrobel, Tomasz, Zafar, Syed F., Cultrera, Jennifer L., Kambhampati, Suman, Danilov, Alexey, Burke, John M., Goldschmidt, Jerome, Beach, Douglas F., Huntington, Scott F., Pinilla Ibarz, Javier, Sharman, Jeff P, Siddiqi, Tanya, Brander, Danielle M., Pagel, John M., Kolibaba, Kathryn S., Dlugosz-Danecka, Monika, Ghosh, Nilanjan, Sportelli, Peter, Miskin, Hari P., O'Connor, Owen A., Weiss, Michael S., and Flinn, Ian W.

Published
2020
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26. Phase 2 study of the safety and efficacy of umbralisib in patients with CLL who are intolerant to BTK or PI3Kδ inhibitor therapy

Author

Mato, Anthony R., primary, Ghosh, Nilanjan, additional, Schuster, Stephen J., additional, Lamanna, Nicole, additional, Pagel, John M., additional, Flinn, Ian W., additional, Barrientos, Jacqueline C., additional, Rai, Kanti R., additional, Reeves, James A., additional, Cheson, Bruce D., additional, Barr, Paul M., additional, Kambhampati, Suman, additional, Lansigan, Frederick, additional, Pu, Jeffrey J., additional, Skarbnik, Alan P., additional, Roeker, Lindsey, additional, Fonseca, Gustavo A., additional, Sitlinger, Andrea, additional, Hamadeh, Issam S., additional, Dorsey, Colleen, additional, LaRatta, Nicole, additional, Weissbrot, Hanna, additional, Luning Prak, Eline T., additional, Tsao, Patricia, additional, Paskalis, Dana, additional, Sportelli, Peter, additional, Miskin, Hari P., additional, Weiss, Michael S., additional, Svoboda, Jakub, additional, and Brander, Danielle M., additional

Published
2021
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27. Umbralisib, a Dual PI3Kδ/CK1ε Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma

Author

Fowler, Nathan H., primary, Samaniego, Felipe, additional, Jurczak, Wojciech, additional, Ghosh, Nilanjan, additional, Derenzini, Enrico, additional, Reeves, James A., additional, Knopińska-Posłuszny, Wanda, additional, Cheah, Chan Y., additional, Phillips, Tycel, additional, Lech-Maranda, Ewa, additional, Cheson, Bruce D., additional, Caimi, Paolo F., additional, Grosicki, Sebastian, additional, Leslie, Lori A., additional, Chavez, Julio C., additional, Fonseca, Gustavo, additional, Babu, Sunil, additional, Hodson, Daniel J., additional, Shao, Spencer H., additional, Burke, John M., additional, Sharman, Jeff P., additional, Law, Jennie Y., additional, Pagel, John M., additional, Miskin, Hari P., additional, Sportelli, Peter, additional, O'Connor, Owen A., additional, Weiss, Michael S., additional, and Zinzani, Pier Luigi, additional

Published
2021
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30. Umbralisib, the Once Daily Dual Inhibitor of PI3Kδ and Casein Kinase-1ε Demonstrates Clinical Activity in Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: Results from the Phase 2 Global Unity-NHL Trial

Author

Zinzani, Pier Luigi, primary, Samaniego, Felipe, additional, Jurczak, Wojciech, additional, Ghosh, Nilanjan, additional, Derenzini, Enrico, additional, Reeves, James A, additional, Knopinska-Posluszny, Wanda, additional, Cheah, Chan Yoon, additional, Phillips, Tycel J., additional, Lech-Marańda, Ewa, additional, Cheson, Bruce D., additional, Caimi, Paolo F, additional, Grosicki, Sebastian, additional, Leslie, Lori A., additional, Chavez, Julio C., additional, Fonseca, Gustavo A., additional, Babu, Sunil, additional, Hodson, Daniel J., additional, Shao, Spencer H., additional, Burke, John M., additional, Sharman, Jeff P, additional, Law, Jennie Y., additional, Pagel, John M., additional, O'Connor, Owen A., additional, Miskin, Hari P., additional, Sportelli, Peter, additional, Weiss, Michael S., additional, and Fowler, Nathan H, additional

Published
2020
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31. A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax (U2-Ven) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Author

Barr, Paul M., primary, Ma, Shuo, additional, Zent, Clive S., additional, Baran, Andrea M., additional, Bui, Andrew, additional, Meacham, Philip J, additional, Morrison, Ashley, additional, Holkovic, Kelsey, additional, Liesveld, Jane L., additional, Mulford, Deborah A, additional, Sportelli, Peter, additional, Miskin, Hari P., additional, Weiss, Michael S., additional, Friedberg, Jonathan W., additional, and Hill, Brian T., additional

Published
2020
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32. Effect of adding ublituximab to ibrutinib on PFS, ORR, and MRD negativity in previously treated high-risk chronic lymphocytic leukemia: Final results of the GENUINE phase III study.

Author

Sharman, Jeff P., primary, Brander, Danielle M., additional, Mato, Anthony R., additional, Ghosh, Nilanjan, additional, Schuster, Stephen J., additional, Kambhampati, Suman, additional, Burke, John M., additional, Lansigan, Frederick, additional, Schreeder, Marshall T., additional, Lunin, Scott D, additional, Zweibach, Alexander, additional, Shtivelband, Mikhail, additional, Travis, Patrick M., additional, Chandler, Jason Claud, additional, Kolibaba, Kathryn S., additional, Sportelli, Peter, additional, Miskin, Hari P., additional, Weiss, Michael S., additional, and Flinn, Ian, additional

Published
2020
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33. Randomized, placebo‐controlled, phase 3 study of perifosine combined with bortezomib and dexamethasone in patients with relapsed, refractory multiple myeloma previously treated with bortezomib

Author

Richardson, Paul G., primary, Nagler, Arnon, additional, Ben‐Yehuda, Dina, additional, Badros, Ashraf, additional, Hari, Parameswaran N., additional, Hajek, Roman, additional, Spicka, Ivan, additional, Kaya, Hakan, additional, LeBlanc, Richard, additional, Yoon, Sung‐Soo, additional, Kim, Kihyun, additional, Martinez‐Lopez, Joaquin, additional, Mittelman, Moshe, additional, Shpilberg, Ofer, additional, Blake, Paul, additional, Hideshima, Teru, additional, Colson, Kathleen, additional, Laubach, Jacob P., additional, Ghobrial, Irene M., additional, Leiba, Merav, additional, Gatt, Moshe E., additional, Sportelli, Peter, additional, Chen, Michael, additional, and Anderson, Kenneth C., additional

Published
2020
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34. A Phase 1/2 Study of Umbralisib Ublituximab and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Author

Barr, Paul M., primary, Hill, Brian T., primary, Ma, Shuo, primary, Baran, Andrea M, primary, Bui, Andrew, primary, Meacham, Philip J, primary, Morrison, Ashley, primary, Liesveld, Jane L., primary, Mulford, Deborah A, primary, Sportelli, Peter, primary, Miskin, Hari P, primary, Weiss, Michael S, primary, Friedberg, Jonathan W., primary, and Zent, Clive S, primary

Published
2019
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35. Abstract CT132: Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: A multicenter, open-label, registration directed Phase II study

Author

Fowler, Nathan H., primary, Samaniego, Felipe, additional, Jurczak, Wojciech, additional, Lech-Maranda, Ewa, additional, Ghosh, Nilanjan, additional, Anz, Bertrand, additional, Patten, Piers, additional, Reeves, James A., additional, Leslie, Lori A., additional, Smolewski, Piotr, additional, Chavez, Julio C., additional, Ghia, Paolo, additional, Tarella, Corrado, additional, Burke, John M., additional, Sharman, Jeff, additional, Kolibaba, Kathryn, additional, O'Connor, Owen A., additional, Cheah, Chan Y., additional, Miskin, Hari P., additional, Sportelli, Peter, additional, Weiss, Michael S., additional, and Zinzani, Pier Luigi, additional

Published
2019
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36. Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: A multicenter, open label, registration directed phase II study.

Author

Fowler, Nathan Hale, primary, Samaniego, Felipe, additional, Jurczak, Wojciech, additional, Lech-Maranda, Ewa, additional, Ghosh, Nilanjan, additional, Patten, Piers, additional, Reeves, James Andrew, additional, Leslie, Lori Ann, additional, Chavez, Julio C., additional, Ghia, Paolo, additional, Tarella, Corrado, additional, Burke, John M., additional, Sharman, Jeff Porter, additional, Kolibaba, Kathryn, additional, O'Connor, Owen A., additional, Cheah, Chan, additional, Miskin, Hari P., additional, Sportelli, Peter, additional, Weiss, Michael S., additional, and Zinzani, Pier Luigi, additional

Published
2019
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37. Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Relapsed/Refractory CLL and Richter's Transformation

Author

Mato, Anthony R., primary, Svoboda, Jakub, additional, Luning Prak, Eline T., additional, Schuster, Stephen J., additional, Tsao, Patricia, additional, Dorsey, Colleen, additional, Becker, Pamela S., additional, Brander, Danielle M., additional, Dwivedy Nasta, Sunita, additional, Landsburg, Daniel J., additional, King, Cara M, additional, Morrigan, Beth, additional, Kennard, Kaitlin, additional, Roeker, Lindsey E., additional, Zelenetz, Andrew D., additional, Purdom, Michelle, additional, Paskalis, Dana, additional, Sportelli, Peter, additional, Miskin, Hari P, additional, Weiss, Michael S., additional, and Shadman, Mazyar, additional

Published
2018
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38. Combination of Umbralisib, Ublituximab, and Bendamustine Is Safe and Highly Active in Patients with Advanced Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

Author

Lunning, Matthew A., primary, Bierman, Philip, additional, Bociek, R. Gregory, additional, Schreeder, Marshall T., additional, Siddiqi, Tanya, additional, Flowers, Christopher R, additional, Cohen, Jonathon B., additional, Blumel, Susan, additional, Cutter, Kathy, additional, Pauli, Emily K., additional, Sportelli, Peter, additional, Miskin, Hari P, additional, Weiss, Michael S., additional, and Vose, Julie M., additional

Published
2018
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40. A phase 2 study to assess the safety and efficacy of umbralisib (TGR-1202) in pts with CLL who are intolerant to prior BTK or PI3Kδ inhibitor therapy.

Author

Mato, Anthony R., primary, Schuster, Stephen J., additional, Lamanna, Nicole, additional, Flinn, Ian, additional, Barrientos, Jacqueline Claudia, additional, Kambhampati, Suman, additional, Cheson, Bruce D., additional, Barr, Paul M., additional, Pagel, John M., additional, Reeves, James Andrew, additional, Lansigan, Frederick, additional, Pu, Jeffrey J., additional, Skarbnik, Alan P., additional, Fonseca, Gustavo A., additional, Dorsey, Colleen, additional, Luning Prak, Eline, additional, Paskalis, Dana, additional, Sportelli, Peter, additional, Miskin, Hari P., additional, and Brander, Danielle M., additional

Published
2018
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41. Umbralisib, a novel PI3Kδ and casein kinase-1ε inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study

Author

Burris, Howard A, primary, Flinn, Ian W, additional, Patel, Manish R, additional, Fenske, Timothy S, additional, Deng, Changchun, additional, Brander, Danielle M, additional, Gutierrez, Martin, additional, Essell, James H, additional, Kuhn, John G, additional, Miskin, Hari P, additional, Sportelli, Peter, additional, Weiss, Michael S, additional, Vakkalanka, Swaroop, additional, Savona, Michael R, additional, and O'Connor, Owen A, additional

Published
2018
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42. Ublituximab and ibrutinib for previously treated genetically high-risk chronic lymphocytic leukemia: Results of the GENUINE phase 3 study.

Author

Sharman, Jeff Porter, primary, Brander, Danielle M., additional, Mato, Anthony R., additional, Kambhampati, Suman, additional, Burke, John M., additional, Lansigan, Frederick, additional, Schreeder, Marshall T., additional, Lunin, Scott D., additional, Ghosh, Nilanjan, additional, Zweibach, Alexander, additional, Shtivelband, Mikhail, additional, Travis, Patrick M., additional, Chandler, Jason Claud, additional, Kolibaba, Kathryn S., additional, Sportelli, Peter, additional, Miskin, Hari P., additional, Weiss, Michael S., additional, and Flinn, Ian, additional

Published
2017
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43. Tolerability and activity of chemo-free triplet combination of TGR-1202, ublituximab, and ibrutinib in patients with advanced CLL and NHL.

Author

Nastoupil, Loretta J., primary, Lunning, Matthew Alexander, additional, Vose, Julie, additional, Schreeder, Marshall T., additional, Siddiqi, Tanya, additional, Flowers, Christopher, additional, Cohen, Jonathon Brett, additional, Burger, Jan Andreas, additional, Wierda, William G., additional, O'Brien, Susan Mary, additional, Sportelli, Peter, additional, Miskin, Hari P., additional, Purdom, Michelle A, additional, Weiss, Michael S., additional, and Fowler, Nathan Hale, additional

Published
2017
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44. KI intolerance study: A phase 2 study to assess the safety and efficacy of TGR-1202 in pts with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K-delta inhibitor therapy.

Author

Dorsey, Colleen, primary, Paskalis, Dana, additional, Brander, Danielle M., additional, Lansigan, Frederick, additional, Barr, Paul M., additional, Lamanna, Nicole, additional, Cheson, Bruce D., additional, Pu, Jeffrey J., additional, Schreeder, Marshall T., additional, Pagel, John M., additional, Sportelli, Peter, additional, Fanning, Molly J, additional, Miskin, Hari P., additional, Zimmer, Tracey, additional, Walsh, Kristy, additional, Schuster, Stephen J., additional, Luning-Prak, Eline T., additional, Wileyto, E. Paul, additional, Weiss, Michael S., additional, and Mato, Anthony R., additional

Published
2017
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45. A phase 1/2 trial of ublituximab, a novel anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab

Author

Sawas, Ahmed, primary, Farber, Charles M., additional, Schreeder, Marshall T., additional, Khalil, Mazen Y., additional, Mahadevan, Daruka, additional, Deng, Changchun, additional, Amengual, Jennifer E., additional, Nikolinakos, Petros G., additional, Kolesar, Jill M., additional, Kuhn, John G., additional, Sportelli, Peter, additional, Miskin, Hari P., additional, and O'Connor, Owen A., additional

Published
2017
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46. Ublituximab (TG-1101), a novel glycoengineered anti-CD20 antibody, in combination with ibrutinib is safe and highly active in patients with relapsed and/or refractory chronic lymphocytic leukaemia: results of a phase 2 trial

Author

Sharman, Jeff P., primary, Farber, Charles M., additional, Mahadevan, Daruka, additional, Schreeder, Marshall T., additional, Brooks, Heather D., additional, Kolibaba, Kathryn S., additional, Fanning, Suzanne, additional, Klein, Leonard, additional, Greenwald, Daniel R., additional, Sportelli, Peter, additional, Miskin, Hari P., additional, Weiss, Michael S., additional, and Burke, John M., additional

Published
2016
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47. Combination of Ublituximab, TGR-1202, and Bendamustine Demonstrates Significant Activity in Patients with Advanced DLBCL and Follicular Lymphoma

Author

Lunning, Matthew, primary, Bierman, Philip J, additional, Bociek, R. Gregory, additional, Schreeder, Marshall T., additional, Blumel, Susan, additional, Cutter, Kathy, additional, Pauli, Emily K., additional, Sportelli, Peter, additional, Miskin, Hari P., additional, Weiss, Michael S., additional, and Vose, Julie M, additional

Published
2016
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49. TGR-1202 in Combination with Ibrutinib in Patients with Relapsed or Refractory CLL or MCL: Preliminary Results of a Multicenter Phase I/Ib Study

Author

Davids, Matthew S., primary, Kim, Haesook T., additional, Nicotra, Alyssa, additional, Savell, Alexandra, additional, Francoeur, Karen, additional, Hellman, Jeffrey, additional, Miskin, Hari P., additional, Sportelli, Peter, additional, Bashey, Asad, additional, Stampleman, Laura, additional, Rueter, Jens, additional, Boruchov, Adam, additional, Arnason, Jon, additional, Jacobson, Caron A., additional, Fisher, David C., additional, and Brown, Jennifer R., additional

Published
2016
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50. Preliminary Results from a Phase I Dose Escalation Trial of Ruxolitinib and the PI3Kδ Inhibitor TGR-1202 in Myelofibrosis

Author

Moyo, Tamara K, primary, Sochacki, Andrew, additional, Ayers, Gregory D, additional, Byrne, Michael T., additional, Strickland, Stephen A., additional, Mohan, Sanjay R., additional, Harrison, Jill, additional, Berry, Lynne D, additional, Dudley, Channing V, additional, Severs, Rachel, additional, Dugger, Laura, additional, Miskin, Hari P., additional, Cavers, Amy, additional, Sportelli, Peter, additional, Michaelis, Laura C, additional, Mesa, Ruben A., additional, and Savona, Michael R., additional

Published
2016
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