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Journal Articles

A Phase II Trial of Acalabrutinib in Combination with PI3Kδ Inhibitor Umbralisib and the Anti-CD20 Antibody Ublituximab (AU2) in Patients with Previously Untreated Mantle Cell Lymphoma (MCL)

Alexey V Danilov, Alexandra Muir, Ivana Melgar, Sandrine Puverel, Peter Sportelli, Hari P. Miskin, Lu Chen, Geoffrey Shouse

Blood (2022) 140 (Supplement 1): 3633–3634.

https://doi.org/10.1182/blood-2022-159805

Published: 2022

Journal Articles

First-in-Human (FIH) Study of the Fully-Human Kappa-Lambda CD19/CD47 Bispecific Antibody TG-1801 in Patients (pts) with B-Cell Lymphoma

Eliza Hawkes, Katharine L. Lewis, Nicole Wong Doo, Sushrut S. Patil, Hari P. Miskin, Peter Sportelli, Kathryn S. Kolibaba, Emmanuel Normant, Tejasvi Turpuseema, Chan Y. Cheah

Blood (2022) 140 (Supplement 1): 6599–6601.

https://doi.org/10.1182/blood-2022-169171

Published: 2022

Journal Articles

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

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

Blood (2021) 138 (Supplement 1): 45.

https://doi.org/10.1182/blood-2021-147425

Published: 2021

Journal Articles

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

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

Blood (2021) 138 (Supplement 1): 527.

https://doi.org/10.1182/blood-2021-151054

Published: 2021

Journal Articles

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

Blood (2021) 138 (Supplement 1): 3726.

https://doi.org/10.1182/blood-2021-147460

Published: 2021

Journal Articles

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

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

Blood (2021) 138 (Supplement 1): 3748.

https://doi.org/10.1182/blood-2021-151292

Published: 2021

Journal Articles

The Ublituximab-Umbralisib (U2) Drug Regimen Potentiates the Activity of the Novel CD47-CD19 Bispecific Antibody, TG-1801, through the Activation of the G Protein-Coupled Receptor EBI2/GPR183

Emmanuel Normant, Marcelo Lima Ribeiro, Nuria Profitos-Peleja, Pedro Blecua, Diana Reyes-Garau, Juliana Carvalho Santos, Marc Armengol, Miranda Fernández-Serrano, Hari P. Miskin, Gael Roue

Blood (2021) 138 (Supplement 1): 1196.

https://doi.org/10.1182/blood-2021-150570

Published: 2021

Journal Articles

The Selective Bruton Tyrosine Kinase (BTK) Inhibitor TG-1701 As Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with B-Cell Malignancies

Chan Yoon Cheah, Wojciech Jurczak, Masa Lasica, Tomasz Wróbel, Stanley Cheung, Jan Walewski, Krzysztof Giannopoulos, Costas K. Yannakou, Katharine L Lewis, Monika Dlugosz-Danecka, Hari P. Miskin, Alejandro D. Ricart, Owen A. O'Connor, Constantine S. Tam

Blood (2021) 138 (Supplement 1): 1549.

https://doi.org/10.1182/blood-2021-145911

Published: 2021

Journal Articles

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

Blood (2021) 138 (Supplement 1): 395.

https://doi.org/10.1182/blood-2021-146999

Published: 2021

Journal Articles

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

Blood (2021) 137 (20): 2817–2826.

https://doi.org/10.1182/blood.2020007376

Published: 2021

Includes: Supplemental data

Journal Articles

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

Blood (2020) 136 (Supplement 1): 34–35.

https://doi.org/10.1182/blood-2020-134851

Published: 2020

Journal Articles

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

Blood (2020) 136 (Supplement 1): 37–39.

https://doi.org/10.1182/blood-2020-134783

Published: 2020

Journal Articles

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

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

Blood (2020) 136 (Supplement 1): 41–42.

https://doi.org/10.1182/blood-2020-134818

Published: 2020

Journal Articles

Ublituximab and umbralisib in relapsed/refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia

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

Blood (2019) 134 (21): 1811–1820.

https://doi.org/10.1182/blood.2019002118

Published: 2019

Includes: Supplemental data

Journal Articles

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

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

Blood (2019) 134 (Supplement_1): 360.

https://doi.org/10.1182/blood-2019-123404

Published: 2019

Journal Articles

Phase 1 Study of TG-1701, a Selective Irreversible Inhibitor of Bruton's Tyrosine Kinase (BTK), in Patients with Relapsed/Refractory B-Cell Malignancies

Chan Y. Cheah, Nicholas Wickham, MBBS, Costas K. Yannakou, MBBS (Hons), FRACP, FRCPA, Katharine L Lewis, FRCPath, MRCP, MBBS, Chi-Hung Hui, MBBS, Pek Sang Tang, MBBS, Tejasvi Turpuseema, Hari P Miskin, MSc, Jian-Ping Tang, PhD, Emmanuel Normant, PhD, Alejandro D. Ricart, MD, Constantine S. Tam, MBBS (Hons), MD

Blood (2019) 134 (Supplement_1): 4001.

https://doi.org/10.1182/blood-2019-126951

Published: 2019

Journal Articles

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

Matthew A. Lunning, DO, Philip Bierman, MD, R. Gregory Bociek, MD, Marshall T. Schreeder, MD, Tanya Siddiqi, MD, Christopher R Flowers, MD MS, Jonathon B. Cohen, MD MS, Susan Blumel, RN, Kathy Cutter, RN, Emily K. Pauli, BMBS,PharmD, Peter Sportelli, BS, Hari P Miskin, MSc, Michael S. Weiss, Julie M. Vose, MD MBA

Blood (2018) 132 (Supplement 1): 4197.

https://doi.org/10.1182/blood-2018-99-118917

Published: 2018

Journal Articles

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

Blood (2018) 132 (Supplement 1): 297.

https://doi.org/10.1182/blood-2018-99-117526

Published: 2018

Journal Articles

KI Intolerance Study: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib (TGR-1202) in Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-δ Inhibitor Therapy

Blood (2017) 130 (Supplement 1): 4314.

https://doi.org/10.1182/blood.V130.Suppl_1.4314.4314

Published: 2017

Journal Articles

PI3K-Delta Inhibitors Induce Primary Monocyte Cytotoxicity but Do Not Alter Monocyte Differentiation

Daphne Friedman, MD, Alicia Volkheimer, Eross Guadalupe, Dave Maryanski, BS, Hari P Miskin, MSc, J. Brice Weinberg, MD

Blood (2017) 130 (Supplement 1): 4284.

https://doi.org/10.1182/blood.V130.Suppl_1.4284.4284

Published: 2017

NARROW

A Phase II Trial of Acalabrutinib in Combination with PI3Kδ Inhibitor Umbralisib and the Anti-CD20 Antibody Ublituximab (AU2) in Patients with Previously Untreated Mantle Cell Lymphoma (MCL)

First-in-Human (FIH) Study of the Fully-Human Kappa-Lambda CD19/CD47 Bispecific Antibody TG-1801 in Patients (pts) with B-Cell Lymphoma

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

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

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

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

The Ublituximab-Umbralisib (U2) Drug Regimen Potentiates the Activity of the Novel CD47-CD19 Bispecific Antibody, TG-1801, through the Activation of the G Protein-Coupled Receptor EBI2/GPR183

The Selective Bruton Tyrosine Kinase (BTK) Inhibitor TG-1701 As Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with B-Cell Malignancies

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

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

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

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

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

Ublituximab and umbralisib in relapsed/refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia

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

Phase 1 Study of TG-1701, a Selective Irreversible Inhibitor of Bruton's Tyrosine Kinase (BTK), in Patients with Relapsed/Refractory B-Cell Malignancies

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

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

KI Intolerance Study: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib (TGR-1202) in Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-δ Inhibitor Therapy

PI3K-Delta Inhibitors Induce Primary Monocyte Cytotoxicity but Do Not Alter Monocyte Differentiation

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American Society of Hematology

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American Society of Hematology

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