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2. Safety of Extended Pirtobrutinib Exposure in Relapsed and/or Refractory B-Cell Malignancies.

Author

Roeker, Lindsey E, Coombs, Catherine C, Shah, Nirav N, Jurczak, Wojciech, Woyach, Jennifer A, Cheah, Chan Y, Patel, Krish, Maddocks, Kami, Wang, Yucai, Zinzani, Pier Luigi, Munir, Talha, Koh, Youngil, Thompson, Meghan C, Muehlenbein, Catherine E, Wang, Chunxiao, Sizelove, Richard, Abhyankar, Sarang, Hasanabba, Safarulla, Tsai, Donald E, Eyre, Toby A, and Wang, Michael

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Patient Safety, Infectious Diseases, Cancer, Clinical Trials and Supportive Activities, Rare Diseases, Hematology, Clinical Research, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, B-cell malignancies, Bruton tyrosine kinase inhibitor, Long-term safety, Toxicity, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

IntroductionPirtobrutinib, a highly selective, noncovalent (reversible) Bruton tyrosine kinase inhibitor, has demonstrated promising efficacy in B-cell malignancies and is associated with low rates of discontinuation and dose reduction. Pirtobrutinib is administered until disease progression or toxicity, necessitating an understanding of the safety profile in patients with extended treatment.MethodsHere we report the safety of pirtobrutinib in patients with relapsed/refractory B-cell malignancies with extended (≥12 months) drug exposure from the BRUIN trial. Assessments included median time-to-first-occurrence of adverse events (AEs), dose reductions, and discontinuations due to treatment-emergent AEs (TEAEs) and select AEs of interest (AESIs).ResultsOf 773 patients enrolled, 326 (42%) received treatment for ≥12 months. In the extended exposure cohort, the median time-on-treatment was 19 months. The most common all-cause TEAEs were fatigue (32%) and diarrhea (31%). TEAEs leading to dose reduction occurred in 23 (7%) and discontinuations in 11 (3%) extended exposure patients. One patient had a fatal treatment-related AE (COVID-19 pneumonia). Infections (73.0%) were the most common AESI with a median time-to-first-occurrence of 7.4 months. Majority of TEAEs and AESIs occurred during the first year of therapy.ConclusionsPirtobrutinib therapy continues to demonstrate an excellent safety profile amenable to long-term administration without evidence of new or worsening toxicity signals.

Published
2024

3. Examining current policies and barriers regarding medications for opioid use disorder within the criminal justice system

Author

Rademeyer, Kara, Thompson, Meghan L., and Mullen, William

Subjects
Prisoners -- Health aspects -- Laws, regulations and rules, Bioethics -- Laws, regulations and rules, Criminal justice, Administration of -- Laws, regulations and rules, Government regulation, Law
Abstract

The Four Pillars of Bioethics within the Criminal Justice System Beneficence Non-maleficence Justice Autonomy Introduction The availability of certain health services for incarcerated individuals in the United States (U.S.) is [...]

Published
2024

5. Mechanisms of Resistance to Noncovalent Brutons Tyrosine Kinase Inhibitors.

Author

Wang, Eric, Mi, Xiaoli, Thompson, Meghan, Montoya, Skye, Notti, Ryan, Afaghani, Jumana, Durham, Benjamin, Penson, Alex, Witkowski, Matthew, Lu, Sydney, Bourcier, Jessie, Hogg, Simon, Erickson, Caroline, Cui, Dan, Cho, Hana, Singer, Michael, Totiger, Tulasigeri, Chaudhry, Sana, Geyer, Mark, Alencar, Alvaro, Linley, Adam, Palomba, M, Coombs, Catherine, Park, Jae, Zelenetz, Andrew, Roeker, Lindsey, Rosendahl, Mary, Tsai, Donald, Ebata, Kevin, Brandhuber, Barbara, Hyman, David, Aifantis, Iannis, Mato, Anthony, Taylor, Justin, and Abdel-Wahab, Omar

Subjects
Humans, Middle Aged, Adenine, Agammaglobulinaemia Tyrosine Kinase, Drug Resistance, Neoplasm, Leukemia, Lymphocytic, Chronic, B-Cell, Mutation, Phospholipase C gamma, Piperidines, Protein Kinase Inhibitors, Receptors, Antigen, B-Cell, Sequence Analysis, RNA, Signal Transduction
Abstract

BACKGROUND: Covalent (irreversible) Brutons tyrosine kinase (BTK) inhibitors have transformed the treatment of multiple B-cell cancers, especially chronic lymphocytic leukemia (CLL). However, resistance can arise through multiple mechanisms, including acquired mutations in BTK at residue C481, the binding site of covalent BTK inhibitors. Noncovalent (reversible) BTK inhibitors overcome this mechanism and other sources of resistance, but the mechanisms of resistance to these therapies are currently not well understood. METHODS: We performed genomic analyses of pretreatment specimens as well as specimens obtained at the time of disease progression from patients with CLL who had been treated with the noncovalent BTK inhibitor pirtobrutinib. Structural modeling, BTK-binding assays, and cell-based assays were conducted to study mutations that confer resistance to noncovalent BTK inhibitors. RESULTS: Among 55 treated patients, we identified 9 patients with relapsed or refractory CLL and acquired mechanisms of genetic resistance to pirtobrutinib. We found mutations (V416L, A428D, M437R, T474I, and L528W) that were clustered in the kinase domain of BTK and that conferred resistance to both noncovalent BTK inhibitors and certain covalent BTK inhibitors. Mutations in BTK or phospholipase C gamma 2 (PLCγ2), a signaling molecule and downstream substrate of BTK, were found in all 9 patients. Transcriptional activation reflecting B-cell-receptor signaling persisted despite continued therapy with noncovalent BTK inhibitors. CONCLUSIONS: Resistance to noncovalent BTK inhibitors arose through on-target BTK mutations and downstream PLCγ2 mutations that allowed escape from BTK inhibition. A proportion of these mutations also conferred resistance across clinically approved covalent BTK inhibitors. These data suggested new mechanisms of genomic escape from established covalent and novel noncovalent BTK inhibitors. (Funded by the American Society of Hematology and others.).

Published
2022

6. Recognizing Unmet Need in the Era of Targeted Therapy for CLL/SLL: “What's Past Is Prologue” (Shakespeare)CLL/SLL Unmet Need

Author

Mato, Anthony R, Davids, Matthew S, Sharman, Jeff, Roeker, Lindsey E, Kay, Neil, Kater, Arnon P, Rogers, Kerry, Thompson, Meghan C, Rhodes, Joanna, Goy, Andre, Skarbnik, Alan, Schuster, Stephen J, Tam, Constantine S, Eyre, Toby A, O'Brien, Susan, Nabhan, Chadi, Lamanna, Nicole, Sun, Clare, Shadman, Mazyar, Pagel, John M, Ujjani, Chaitra, Brander, Danielle, Coombs, Catherine C, Jain, Nitin, Cheah, Chan Y, Brown, Jennifer R, Seymour, John F, and Woyach, Jennifer A

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Clinical Research, Hematology, Lymphoma, Cancer, Humans, Immunotherapy, Leukemia, Lymphocytic, Chronic, B-Cell, Phosphatidylinositol 3-Kinases, Protein Kinase Inhibitors, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

The management of chronic lymphocytic leukemia (CLL) has undergone unprecedented changes over the last decade. Modern targeted therapies are incorporated into clinical practice. Unfortunately, patients have begun to develop resistance or intolerance to multiple classes. Symptomatic patients previously treated with a BTK inhibitor (BTKi) and venetoclax represent a new and rapidly growing unmet need in CLL. Here, we define unmet needs in a modern treatment context. We also critically review the literature for PI3K inhibitors and chemoimmunotherapy and lack of data to support their utility following BTKis and venetoclax. Finally, we suggest opportunities to ensure the continued innovation for patients with CLL.

Published
2022

8. Zanubrutinib, obinutuzumab, and venetoclax with minimal residual disease-driven discontinuation in previously untreated patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: a multicentre, single-arm, phase 2 trial

Author

Soumerai, Jacob D, Mato, Anthony R, Dogan, Ahmet, Seshan, Venkatraman E, Joffe, Erel, Flaherty, Kelsey, Carter, Jason, Hochberg, Ephraim, Barnes, Jeffrey A, Hamilton, Audrey M, Abramson, Jeremy S, Batlevi, Connie L, Matasar, Matthew J, Noy, Ariela, Owens, Colette N, Palomba, M Lia, Kumar, Anita, Takvorian, Tak, Ni, Ai, Choma, Morgan, Friedman, Chaya, Chadha, Puja, Simkins, Elizabeth, Ruiters, Jade, Sechio, Sidney, Portman, Daneal, Ramos, Lauren, Nolet, Natascha, Mahajan, Neena, Martignetti, Rosalba, Mi, Joanna, Scorsune, Krista, Lynch, Julia, McGree, Brianne, Hughes, Stephanie, Grieve, Clare, Roeker, Lindsey E, Thompson, Meghan, Johnson, P Connor, Roshal, Mikhail, Huang, Jane, Biondo, Juliana, Wu, Qun, Jacob, Allison, Abdel-Wahab, Omar, and Zelenetz, Andrew D

Published
2021
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9. COVID-19 in patients with CLL: improved survival outcomes and update on management strategies

Author

Roeker, Lindsey E., Eyre, Toby A., Thompson, Meghan C., Lamanna, Nicole, Coltoff, Alexander R., Davids, Matthew S., Baker, Peter O., Leslie, Lori, Rogers, Kerry A., Allan, John N., Cordoba, Raul, Lopez-Garcia, Alberto, Antic, Darko, Pagel, John M., Martinez-Calle, Nicolas, García-Marco, José Antonio, Hernández‐Rivas, Jose‐Ángel, Miras, Fatima, Coombs, Catherine C., Österborg, Anders, Hansson, Lotta, Seddon, Amanda N., López Jiménez, Javier, Wilson, Matthew R., El-Sharkawi, Dima, Wojenski, Daniel, Ma, Shuo, Munir, Talha, Valenciano, Susana, Seymour, Erlene, Barr, Paul M., Pu, Jeffrey, Patten, Piers E.M., Perini, Guilherme F., Huntington, Scott F., Parry, Helen, Sundaram, Suchitra, Skarbnik, Alan, Kamdar, Manali, Jacobs, Ryan, Walter, Harriet, Walewska, Renata, Broom, Angus, Lebowitz, Sonia, Isaac, Krista M., Portell, Craig A., Ahn, Inhye E., Ujjani, Chaitra S., Shadman, Mazyar, Skånland, Sigrid S., Chong, Elise A., and Mato, Anthony R.

Published
2021
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11. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 2.2024

Author

Wierda, William G., primary, Brown, Jennifer, additional, Abramson, Jeremy S., additional, Awan, Farrukh, additional, Bilgrami, Syed F., additional, Bociek, Greg, additional, Brander, Danielle, additional, Cortese, Matthew, additional, Cripe, Larry, additional, Davis, Randall S., additional, Eradat, Herbert, additional, Fakhri, Bita, additional, Fletcher, Christopher D., additional, Gaballa, Sameh, additional, Hamid, Muhammad Saad, additional, Hill, Brian, additional, Kaesberg, Paul, additional, Kahl, Brad, additional, Kamdar, Manali, additional, Kipps, Thomas J., additional, Ma, Shuo, additional, Mosse, Claudio, additional, Nakhoda, Shazia, additional, Parikh, Sameer, additional, Schorr, Andrew, additional, Schuster, Stephen, additional, Seshadri, Madhav, additional, Siddiqi, Tanya, additional, Stephens, Deborah M., additional, Thompson, Meghan, additional, Ujjani, Chaitra, additional, Valdez, Riccardo, additional, Wagner-Johnston, Nina, additional, Woyach, Jennifer A., additional, Sundar, Hema, additional, and Dwyer, Mary, additional

Published
2024
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13. COVID-19 vaccine efficacy in patients with chronic lymphocytic leukemia

Author

Roeker, Lindsey E., Knorr, David A., Thompson, Meghan C., Nivar, Mariely, Lebowitz, Sonia, Peters, Nicole, Deonarine, Jr, Isaac, Momotaj, Saddia, Sharan, Saumya, Chanlatte, Vanessa, Hampton, Bianca, Butala, Liana, Amato, Lindsay, Richford, Angela, Lunkenheimer, Jessica, Battiato, Kristen, Laudati, Carissa, and Mato, Anthony R.

Published
2021
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14. Kinase-impaired BTK mutations are susceptible to clinical-stage BTK and IKZF1/3 degrader NX-2127

Author

Montoya, Skye, primary, Bourcier, Jessie, additional, Noviski, Mark, additional, Lu, Hao, additional, Thompson, Meghan C., additional, Chirino, Alexandra, additional, Jahn, Jacob, additional, Sondhi, Anya K., additional, Gajewski, Stefan, additional, Tan, Ying Siow (May), additional, Yung, Stephanie, additional, Urban, Aleksandra, additional, Wang, Eric, additional, Han, Cuijuan, additional, Mi, Xiaoli, additional, Kim, Won Jun, additional, Sievers, Quinlan, additional, Auger, Paul, additional, Bousquet, Hugo, additional, Brathaban, Nivetha, additional, Bravo, Brandon, additional, Gessner, Melissa, additional, Guiducci, Cristiana, additional, Iuliano, James N., additional, Kane, Tim, additional, Mukerji, Ratul, additional, Reddy, Panga Jaipal, additional, Powers, Janine, additional, Sanchez Garcia de los Rios, Mateo, additional, Ye, Jordan, additional, Barrientos Risso, Carla, additional, Tsai, Daniel, additional, Pardo, Gabriel, additional, Notti, Ryan Q., additional, Pardo, Alejandro, additional, Affer, Maurizio, additional, Nawaratne, Vindhya, additional, Totiger, Tulasigeri M., additional, Pena-Velasquez, Camila, additional, Rhodes, Joanna M., additional, Zelenetz, Andrew D., additional, Alencar, Alvaro, additional, Roeker, Lindsey E., additional, Mehta, Sanjoy, additional, Garippa, Ralph, additional, Linley, Adam, additional, Soni, Rajesh Kumar, additional, Skånland, Sigrid S., additional, Brown, Robert J., additional, Mato, Anthony R., additional, Hansen, Gwenn M., additional, Abdel-Wahab, Omar, additional, and Taylor, Justin, additional

Published
2024
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18. Novel identification of t(14;18)(q32;q21)/IGH::MALT1 in chronic lymphocytic leukaemia.

Author

Kumar, Jyoti, Ewalt, Mark D., Zhang, Yanming, Yao, JinJuan, Thompson, Meghan C., and Dogan, Ahmet

Subjects
LYMPHOCYTIC leukemia, IMMUNOGLOBULIN heavy chains, CHRONIC leukemia, CHRONIC lymphocytic leukemia, LYMPHOMAS
Abstract

Summary: Chronic lymphocytic leukaemia (CLL) is a clonal B‐cell malignancy and remains a chronic disease despite improvements in clinical outcomes since the use of targeted therapies. Both clinical and biological parameters are important for determining prognosis. Unlike other mature B‐cell lymphomas, translocations involving the immunoglobulin heavy chain (IGH) locus are uncommon in CLL. There have been few case reports of CLL harbouring t(14;18)/IGH::BCL2 and t(14;19)/IGH::BCL3. Here we describe the first two cases of patients with CLL with documented t(14;18)(q32;q21)/IGH::MALT1. Both cases in this report were associated with lower‐risk biological parameters. Thus, FISH testing for MALT1 in cases with unknown IGH translocation partners in the setting of CLL should be implemented in clinical practice to better define such cases. [ABSTRACT FROM AUTHOR]

Published
2024
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20. 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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21. 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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22. Kinase Dead BTK Mutations Confer Resistance to Covalent and Noncovalent BTK Inhibitors but Are Susceptible to Clinical Stage BTK Degraders

Author

Montoya, Skye, primary, Bourcier, Jessie, additional, Thompson, Meghan C., additional, Noviski, Mark, additional, Tan, May, additional, Wang, Eric, additional, Mi, Xiaoli, additional, Brathaban, Nivetha, additional, Barrientos Risso, Carla, additional, Tsai, Daniel, additional, Ye, Jordan, additional, Jahn, Jacob, additional, Pardo, Gabriel, additional, Cabuhat, Lee, additional, Notti, Ryan, additional, Pardo, Alejandro, additional, Affer, Maurizio, additional, Yung, Stephanie, additional, Luliano, James, additional, Powers, Janine, additional, Robbins, Daniel W, additional, Nawaratne, Vindhya, additional, Totiger, Tulasigeri M, additional, Pena-Velasquez, Camila, additional, Rhodes, Joanna M., additional, Zelenetz, Andrew D., additional, Roeker, Lindsey E., additional, Lu, Hao, additional, Linley, Adam, additional, Mato, Anthony R., additional, Abdel-Wahab, Omar, additional, and Taylor, Justin, additional

Published
2022
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23. Safety and Tolerability of Pirtobrutinib Monotherapy in Patients with B-Cell Malignancies Who Were Previously Intolerant to a Covalent BTK Inhibitor: Results from the Phase 1/2 BRUIN Study

Author

Shah, Nirav N., primary, Wang, Michael L., additional, Brown, Jennifer R., additional, Patel, Krish, additional, Woyach, Jennifer A., additional, Wierda, William G., additional, Ujjani, Chaitra S., additional, Eyre, Toby A., additional, Zinzani, Pier Luigi, additional, Alencar, Alvaro J., additional, Gastinne, Thomas, additional, Ghia, Paolo, additional, Lamanna, Nicole, additional, Hoffmann, Marc, additional, Patel, Manish R., additional, Flinn, Ian W., additional, Gerson, James N., additional, Ma, Shuo, additional, Coombs, Catherine C., additional, Cheah, Chan Y., additional, Lech-Marańda, Ewa, additional, Fakhri, Bita, additional, Kim, Won-Seog, additional, Barve, Minal A., additional, Cohen, Jonathon B., additional, Jurczak, Wojciech, additional, Munir, Talha, additional, Thompson, Meghan C., additional, Roeker, Lindsey E., additional, Bao, Katherine, additional, Cangemi, Nicholas A., additional, Kherani, Jennifer F., additional, Walgren, Richard A., additional, Han, Hongmei, additional, Ruppert, Amy S., additional, and Mato, Anthony R., additional

Published
2022
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24. Outcomes of Therapies and Resistance Mutations Following Non-Covalent Bruton's Tyrosine Kinase Inhibitor Treatment for Patients with Chronic Lymphocytic Leukemia and Richter Transformation

Author

Thompson, Meghan C., primary, Coombs, Catherine C., additional, Roeker, Lindsey E., additional, Jensen, Jeffrey L., additional, Shah, Nirav N., additional, Luo, Thomas, additional, Patel, Krish, additional, Bailey, Neil, additional, Fakhri, Bita, additional, Eyre, Toby A., additional, Ghione, Paola, additional, Rhodes, Joanna M., additional, Zelenetz, Andrew D., additional, Taylor, Justin, additional, Palomba, Maria Lia, additional, Meyer, Kendall, additional, Rao, Danielle, additional, Fox, Yehudit, additional, Aronson, Julia H., additional, Court, Sarah, additional, Abdel-Wahab, Omar, additional, and Mato, Anthony R., additional

Published
2022
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26. 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

27. Venetoclax retreatment of patients with chronic lymphocytic leukemia after a previous venetoclax-based regimen

Author

Thompson, Meghan C., Harrup, Rosemary A., Coombs, Catherine C., Roeker, Lindsey E., Pu, Jeffrey J., Choi, Michael Y., Barr, Paul M., Allan, John N., Šimkovič, Martin, Leslie, Lori, Rhodes, Joanna, Chong, Elise A., Kamdar, Manali, Skarbnik, Alan, Lansigan, Frederick, McCall, Brittany, Saja, Khalid, Dyer, Martin J.S., Walter, Harriet S., Lefebure, Marcus, Thadani-Mulero, Maria, Boyer, Michelle, Biondo, Juliana, Sail, Kavita, Manzoor, Beenish S., Furman, Richard, Bantilan, Kurt S., Goy, Andre, Feldman, Tatyana, Labella, Dominic, Schuster, Stephen J., Park, Jae, Palomba, Lia, Zelenetz, Andrew, Eyre, Toby A., Kater, Arnon P., Seymour, John F., and Mato, Anthony R.

Published
2022
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29. 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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30. CLL-495 Treatment Characteristics and Outcomes of Patients With Chronic/Small Lymphocytic Leukemia (CLL) Treated With Venetoclax and Bruton Tyrosine Kinase Inhibitor (BTKi) Combination Therapies

Author

Tuncer, Hande H., Ghosh, Nilanjan, Fleury, Isabelle, Leslie, Lori A., Manzoor, Beenish S., Lamanna, Nicole, Eyre, Toby A., Hill, Brian T., Brown, Jennifer R., Sinai, Wendy, Coombs, Catherine C., Ujjani, Chaitra, Roeker, Lindsey E., Emechebe, Nnadozie, Barr, Paul M., Davids, Matthew S., Martinez-Calle, Nicolas, Rhodes, Joanna M., Lansigan, Frederick, Pearson, Laurie, Choi, Yun, Schuster, Stephen J., Skarbnik, Alan P., Fakhri, Bita, Coyle, Michael, Stephens, Deborah M., Thompson, Meghan C., Jensen, Christopher E., Marx, Steven E., Jawaid, Dureshahwar, Schuh, Anna, Pivneva, Irina, Watson, Talissa, Guerin, Annie, and Shadman, Mazyar

Published
2024
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34. Treatment Characteristics and Outcomes of Patients With Chronic/Small Lymphocytic Leukemia (CLL) Treated With Venetoclax and Bruton Tyrosine Kinase Inhibitor (BTKi) Combination Therapies

Author

Tuncer, Hande H., Ghosh, Nilanjan, Fleury, Isabelle, Leslie, Lori A., Manzoor, Beenish S., Lamanna, Nicole, Eyre, Toby A., Hill, Brian T., Brown, Jennifer R., Sinai, Wendy, Coombs, Catherine C., Ujjani, Chaitra, Roeker, Lindsey E., Emechebe, Nnadozie, Barr, Paul M., Davids, Matthew S., Martinez-Calle, Nicolas, Rhodes, Joanna M., Lansigan, Frederick, Pearson, Laurie, Choi, Yun, Schuster, Stephen J., Skarbnik, Alan P., Fakhri, Bita, Coyle, Michael, Stephens, Deborah M., Thompson, Meghan C., Jensen, Christopher E., Marx, Steven E., Jawaid, Dureshahwar, Schuh, Anna, Pivneva, Irina, Watson, Talissa, Guerin, Annie, and Shadman, Mazyar

Published
2024
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36. Recognizing Unmet Need in the Era of Targeted Therapy for CLL/SLL: 'What's Past Is Prologue' (Shakespeare).

Author

Mato, Anthony R, Mato, Anthony R, Davids, Matthew S, Sharman, Jeff, Roeker, Lindsey E, Kay, Neil, Kater, Arnon P, Rogers, Kerry, Thompson, Meghan C, Rhodes, Joanna, Goy, Andre, Skarbnik, Alan, Schuster, Stephen J, Tam, Constantine S, Eyre, Toby A, O'Brien, Susan, Nabhan, Chadi, Lamanna, Nicole, Sun, Clare, Shadman, Mazyar, Pagel, John M, Ujjani, Chaitra, Brander, Danielle, Coombs, Catherine C, Jain, Nitin, Cheah, Chan Y, Brown, Jennifer R, Seymour, John F, Woyach, Jennifer A, Mato, Anthony R, Mato, Anthony R, Davids, Matthew S, Sharman, Jeff, Roeker, Lindsey E, Kay, Neil, Kater, Arnon P, Rogers, Kerry, Thompson, Meghan C, Rhodes, Joanna, Goy, Andre, Skarbnik, Alan, Schuster, Stephen J, Tam, Constantine S, Eyre, Toby A, O'Brien, Susan, Nabhan, Chadi, Lamanna, Nicole, Sun, Clare, Shadman, Mazyar, Pagel, John M, Ujjani, Chaitra, Brander, Danielle, Coombs, Catherine C, Jain, Nitin, Cheah, Chan Y, Brown, Jennifer R, Seymour, John F, and Woyach, Jennifer A

Abstract

The management of chronic lymphocytic leukemia (CLL) has undergone unprecedented changes over the last decade. Modern targeted therapies are incorporated into clinical practice. Unfortunately, patients have begun to develop resistance or intolerance to multiple classes. Symptomatic patients previously treated with a BTK inhibitor (BTKi) and venetoclax represent a new and rapidly growing unmet need in CLL. Here, we define unmet needs in a modern treatment context. We also critically review the literature for PI3K inhibitors and chemoimmunotherapy and lack of data to support their utility following BTKis and venetoclax. Finally, we suggest opportunities to ensure the continued innovation for patients with CLL.

Published
2022

40. Recognizing Unmet Need in the Era of Targeted Therapy for CLL/SLL: “What's Past Is Prologue” (Shakespeare)

Author

Mato, Anthony R., primary, Davids, Matthew S., additional, Sharman, Jeff, additional, Roeker, Lindsey E., additional, Kay, Neil, additional, Kater, Arnon P., additional, Rogers, Kerry, additional, Thompson, Meghan C., additional, Rhodes, Joanna, additional, Goy, Andre, additional, Skarbnik, Alan, additional, Schuster, Stephen J., additional, Tam, Constantine S., additional, Eyre, Toby A., additional, O'Brien, Susan, additional, Nabhan, Chadi, additional, Lamanna, Nicole, additional, Sun, Clare, additional, Shadman, Mazyar, additional, Pagel, John M., additional, Ujjani, Chaitra, additional, Brander, Danielle, additional, Coombs, Catherine C., additional, Jain, Nitin, additional, Cheah, Chan Y., additional, Brown, Jennifer R., additional, Seymour, John F., additional, and Woyach, Jennifer A., additional

Published
2021
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41. Addressing a New Challenge in Chronic Lymphocytic Leukemia: Outcomes of Therapies after Exposure to Both a Covalent Bruton's Tyrosine Kinase Inhibitor and Venetoclax

Author

Thompson, Meghan C., primary, Roeker, Lindsey E., additional, Coombs, Catherine C., additional, Jensen, Jeffrey L., additional, Kamdar, Manali, additional, Skarbnik, Alan, additional, Pagel, John M., additional, Bailey, Neil, additional, Pu, Jeffrey J., additional, Jacobs, Ryan, additional, Hill, Brian T., additional, Brander, Danielle M., additional, Shadman, Mazyar, additional, Ujjani, Chaitra S., additional, Battiato, Kristen E., additional, Komari, Celina J., additional, Sacchi De Camargo Correia, Guilherme, additional, Aronson, Julia H., additional, Rhodes, Joanna M, additional, Ghione, Paola, additional, Fakhri, Bita, additional, Barr, Paul M., additional, Portell, Craig A., additional, Lamanna, Nicole, additional, Pinilla-Ibarz, Javier, additional, Zelenetz, Andrew D., additional, Schuster, Stephen J, additional, Allan, John N., additional, Eyre, Toby A., additional, and Mato, Anthony R., additional

Published
2021
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42. Outcomes of Chronic Lymphocytic Leukemia and Richter Transformation Following Discontinuation of Non-Covalent Bruton's Tyrosine Kinase Inhibitors

Author

Thompson, Meghan C., primary, Coombs, Catherine C., additional, Roeker, Lindsey E., additional, Pagel, John M., additional, Jensen, Jeffrey L., additional, Battiato, Kristen E., additional, Fox, Yehudit, additional, Meyer, Kendall, additional, Bailey, Neil, additional, Rhodes, Joanna M, additional, Ghione, Paola, additional, Fakhri, Bita, additional, Eyre, Toby A., additional, and Mato, Anthony R., additional

Published
2021
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44. 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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45. Zanubrutinib, Obinutuzumab, and Venetoclax in Chronic Lymphocytic Leukemia: Early MRD Kinetics Define a High-Risk Patient Cohort with Delayed Bone Marrow Undetectable MRD and Earlier Post-Treatment MRD Recurrence

Author

Soumerai, Jacob D., primary, Mato, Anthony R., additional, Dogan, Ahmet, additional, Seshan, Venkatraman, additional, Joffe, Erel, additional, Flaherty, Kelsey, additional, Carter, Jason, additional, Hochberg, Ephraim P, additional, Barnes, Jeffrey A, additional, Hamilton, Audrey, additional, Abramson, Jeremy S., additional, Batlevi, Connie Lee, additional, Matasar, Matthew J., additional, Noy, Ariela, additional, Owens, Colette, additional, Palomba, M. Lia, additional, Kumar, Anita, additional, Takvorian, Tak, additional, Ni, Ai, additional, Choma, Morgan, additional, Friedman, Chaya, additional, Chadha, Puja, additional, Simkins, Elizabeth, additional, Ruiters, Jade, additional, Sechio, Sidney, additional, Portman, Daneal, additional, Nolet, Natascha, additional, Mahajan, Neena, additional, Martignetti, Rosalba, additional, Mi, Joanna, additional, Scorsune, Krista J, additional, Lynch, Julia M, additional, McGree, Brianne, additional, Hughes, Stephanie Y, additional, Grieve, Clare, additional, Roeker, Lindsey E., additional, Thompson, Meghan C., additional, Johnson, P. Connor, additional, Roshal, Mikhail, additional, Huang, Jane, additional, Biondo, Juliana M.L., additional, Wu, Jenny Qun, additional, Jacob, Allison P., additional, Abdel-Wahab, Omar, additional, and Zelenetz, Andrew D., additional

Published
2021
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46. Outcomes of patients with Richter transformation who received no prior chemoimmunotherapy for their CLL

Author

Kittai, Adam S., Huang, Ying, Miller, Sarah, Allan, John N., Bhat, Seema A., Bond, David A., Brander, Danielle M., Byrd, John C., Chavez, Julio C., Chong, Elise, Davids, Matthew S., Danilov, Alexey V., Ding, Wei, Dowling, Mark R., Dvorak-Kornaus, Kaitlyn, Freedman, Hannah, Hampel, Paul J., Ho, Carrie, Hwang, Steven R., Islam, Prioty, Malakhov, Nikita, Matasar, Matthew, Miller, Cecelia, Omer, Zulfa, Parikh, Sameer A., Parry, Erin, Rabe, Kari G., Raess, Philipp W., Rai, Manoj, Roeker, Lindsey, Rhodes, Joanna, Rogers, Kerry A., Saha, Aditi, Schade, Jake, Scott, Hamish W., Shadman, Mazyar, Shouse, Geoffrey, Skarbnik, Alan, Spurgeon, Stephen, Stephens, Deborah M., Thompson, Meghan C., Thompson, Philip A., Wang, Yucai, Yano, Max, and Woyach, Jennifer A.

Published
2025
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48. From research to practice: EnhanceFitness, an innovative community-based senior exercise program

Author

Belza, Basia, Snyder, Susan, Thompson, Meghan, and LoGerfo, James

Subjects
Exercise therapy -- Management, Exercise therapy -- Demographic aspects, Physical fitness -- Management, Physical fitness -- Demographic aspects, Aged -- Health aspects, Community health services -- Management, Evidence-based medicine -- Practice, Exercise therapy for the aged -- Management, Exercise therapy for the aged -- Demographic aspects, Physical fitness for the aged -- Management, Physical fitness for the aged -- Demographic aspects, Community health services for the aged -- Management, Company business management, Health, Seniors
Published
2010

49. Venetoclax Re-Treatment of Chronic Lymphocytic Leukemia (CLL) Patients after a Previous Venetoclax-Based Regimen

Author

Thompson, Meghan C., Allan, John N., Sail, Kavita, Manzoor, Beenish S., Pu, Jeffrey J., Barr, Paul M., Coombs, Catherine C., Schuster, Stephen J., Skarbnik, Alan, Rhodes, Joanna M, Barrientos, Jacqueline C., Roeker, Lindsey E, Leslie, Lori A., Kamdar, Manali, Choi, Michael Y., Simkovic, Martin, Lansigan, Frederick, Hale, Brittany Jane, Zelenetz, Andrew D, Moskowitz, Alison J., Bantilan, Kurt S., Komari, Celina J., Goy, Andre H., Feldman, Tatyana A., Furman, Richard R., and Mato, Anthony R.

Published
2020
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50. Worldwide Examination of Patients with CLL Hospitalized for COVID-19

Author

Roeker, Lindsey E, Scarfo, Lydia, Chatzikonstantinou, Thomas, Abrisqueta, Pau, Eyre, Toby A., Cordoba, Raul, Muntañola Prat, Ana, Villacampa, Guillermo, Leslie, Lori A., Koropsak, Michael, Quaresmini, Giulia, Allan, John N., Furman, Richard R., Bhavsar, Erica B, Pagel, John M., Hernandez-Rivas, Jose Angel, Patel, Krish, Motta, Marina, Bailey, Neil, Miras, Fatima, Lamanna, Nicole, Alonso, Rosalia, Osorio-Prendes, Santiago, Vitale, Candida, Kamdar, Manali, Baltasar, Patricia, Österborg, Anders, Hanson, Lotta, Baile, Mónica, Rodríguez-Hernández, Ines, Valenciano, Susana, Popov, Viola Maria, Barez Garcia, Abelardo, Alfayate, Ana, Oliveira, Ana C, Eichhorst, Barbara, Quaglia, Francesca M., Reda, Gianluigi, Lopez Jimenez, Javier, Varettoni, Marzia, Marchetti, Monia, Romero, Pilar, Riaza Grau, Rosalía, Munir, Talha, Zabalza, Amaya, Janssens, Ann, Niemann, Carsten U, Perini, Guilherme Fleury, Delgado, Julio, Yanez San Segundo, Lucrecia, Gómez Roncero, Ma Isabel, Wilson, Matthew, Patten, Piers, Marasca, Roberto, Iyengar, Sunil, Seddon, Amanda, Torres, Ana, Ferrari, Angela, Cuéllar-García, Carolina, Wojenski, Daniel, El-Sharkawi, Dima, Itchaki, Gilad, Parry, Helen, Mateos-Mazón, Juan José, Martinez-Calle, Nicolas, Ma, Shuo, Naya, Daniel, Van Der Spek, Ellen, Seymour, Erlene K., Gimeno Vázquez, Eva, Rigolin, Gian Matteo, Mauro, Francesca Romana, Walter, Harriet S, Labrador, Jorge, De Paoli, Lorenzo, Laurenti, Luca, Ruiz, Elena, Levin, Mark-David, Šimkovič, Martin, Špaček, Martin, Andreu, Rafa, Walewska, Renata, Perez-Gonzalez, Sonia, Sundaram, Suchitra, Wiestner, Adrian, Cuesta, Amalia, Broom, Angus, Kater, Arnon P., Muiña, Begoña, Velasquez, César A, Ujjani, Chaitra S., Seri, Cristina, Antic, Darko, Bron, Dominique, Vandenberghe, Elisabeth, Chong, Elise A., Lista, Enrico, García, Fiz Campoy, Del Poeta, Giovanni, Ahn, Inhye, Pu, Jeffrey J., Brown, Jennifer R, Soler Campos, Juan Alfonso, Malerba, Lara, Trentin, Livio, Orsucci, Lorella, Farina, Lucia, Villalon, Lucia, Vidal, Maria Jesus, Sanchez, Maria Jose, Terol, Maria Jose, De Paolis, Maria Rosaria, Gentile, Massimo, Davids, Matthew S., Shadman, Mazyar, Yassin, Mohamed A, Foglietta, Myriam, Jaksic, Ozren, Sportoletti, Paolo, Barr, Paul M., Ramos, Rafael, Santiago, Raquel, Ruchlemer, Rosa, Kersting, Sabina, Huntington, Scott F., Herold, Tobias, Herishanu, Yair, Thompson, Meghan C., Lebowitz, Sonia, Ryan, Christine, Jacobs, Ryan W., Portell, Craig A., Isaac, Krista, Rambaldi, Alessandro, Nabhan, Chadi, Brander, Danielle M., Montserrat, Emili, Rossi, Giuseppe, Garcia-Marco, Jose A., Sr., Coscia, Marta, Malakhov, Nikita, Fernandez-Escalada, Noemi, Skånland, Sigrid Strand, Coombs, Callie C., Ghione, Paola, Schuster, Stephen J., Foà, Robin, Cuneo, Antonio, Bosch, Francesc, Stamatopoulos, Kostas, Ghia, Paolo, Mato, Anthony R., and Patel, Meera

Published
2020
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