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3. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia.

Author

Kreitman, Robert, Dearden, Claire, Zinzani, Pier, Delgado, Julio, Karlin, Lionel, Robak, Tadeusz, Gladstone, Douglas, le Coutre, Philipp, Dietrich, Sascha, Gotic, Mirjana, Larratt, Loree, Offner, Fritz, Schiller, Gary, Swords, Ronan, Bacon, Larry, Bocchia, Monica, Bouabdallah, Krimo, Breems, Dimitri, Cortelezzi, Agostino, Dinner, Shira, Doubek, Michael, Gjertsen, Bjorn, Gobbi, Marco, Hellmann, Andrzej, Lepretre, Stephane, Maloisel, Frederic, Ravandi, Farhad, Rousselot, Philippe, Rummel, Mathias, Siddiqi, Tanya, Tadmor, Tamar, Troussard, Xavier, Yi, Cecilia, Saglio, Giuseppe, Roboz, Gail, Balic, Kemal, Standifer, Nathan, He, Peng, Marshall, Shannon, Wilson, Wyndham, Pastan, Ira, Yao, Nai-Shun, and Giles, Francis

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Bacterial Toxins, Drug Resistance, Neoplasm, Exotoxins, Female, Follow-Up Studies, Humans, Leukemia, Hairy Cell, Male, Middle Aged, Neoplasm Recurrence, Local, Prognosis, Remission Induction, Salvage Therapy, Survival Rate
Abstract

This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/refractory HCL who had ≥2 prior systemic therapies, including ≥1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 µg/kg intravenously on days 1, 3, and 5 every 28 days for ≤6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.

Published
2018

5. Perioperative oral eltrombopag versus intravenous immunoglobulin in patients with immune thrombocytopenia: a non-inferiority, multicentre, randomised trial

Author

Arnold, Donald M, Heddle, Nancy M, Cook, Richard J, Hsia, Cyrus, Blostein, Mark, Jamula, Erin, Sholzberg, Michelle, Lin, Yulia, Kassis, Jeannine, Larratt, Loree, Tinmouth, Alan, Amini, Sufia, Schipperus, Martin, Lim, Wendy, Vishnu, Prakash, Warner, Margaret, Carruthers, Julie, Li, Na, Lane, Shannon, and Kelton, John G

Published
2020
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8. Consensus guidelines for the diagnosis and management of patients with classic hairy cell leukemia

Author

Grever, Michael R., Abdel-Wahab, Omar, Andritsos, Leslie A., Banerji, Versha, Barrientos, Jacqueline, Blachly, James S., Call, Timothy G., Catovsky, Daniel, Dearden, Claire, Demeter, Judit, Else, Monica, Forconi, Francesco, Gozzetti, Alessandro, Ho, Anthony D., Johnston, James B., Jones, Jeffrey, Juliusson, Gunnar, Kraut, Eric, Kreitman, Robert J., Larratt, Loree, Lauria, Francesco, Lozanski, Gerard, Montserrat, Emili, Parikh, Sameer A., Park, Jae H., Polliack, Aaron, Quest, Graeme R., Rai, Kanti R., Ravandi, Farhad, Robak, Tadeusz, Saven, Alan, Seymour, John F., Tadmor, Tamar, Tallman, Martin S., Tam, Constantine, Tiacci, Enrico, Troussard, Xavier, Zent, Clive S., Zenz, Thorsten, Zinzani, Pier Luigi, and Falini, Brunangelo

Published
2017
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11. Low Counts of B Cells, Natural Killer Cells, Monocytes, Dendritic Cells, Basophils, and Eosinophils are Associated with Postengraftment Infections after Allogeneic Hematopoietic Cell Transplantation

Author

Podgorny, Peter J., Pratt, Laura M., Liu, Yiping, Dharmani-Khan, Poonam, Luider, Joanne, Auer-Grzesiak, Iwona, Mansoor, Adnan, Williamson, Tyler S., Ugarte-Torres, Alejandra, Hoegh-Petersen, Mette, Khan, Faisal M., Larratt, Loree, Jimenez-Zepeda, Victor H., Stewart, Douglas A., Russell, James A., Daly, Andrew, and Storek, Jan

Published
2016
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14. First-line treatment of chronic lymphocytic leukemia with ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab: final analysis of the randomized, phase III iLLUMINATE trial

Author

Moreno, Carol, primary, Greil, Richard, additional, Demirkan, Fatih, additional, Tedeschi, Alessandra, additional, Anz, Bertrand, additional, Larratt, Loree, additional, Simkovic, Martin, additional, Novak, Jan, additional, Strugov, Vladimir, additional, Gill, Devinder, additional, Gribben, John G., additional, Kwei, Kevin, additional, Dai, Sandra, additional, Hsu, Emily, additional, Dean, James P., additional, and Flinn, Ian W., additional

Published
2022
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17. Expanded antigen-experienced CD160+CD8+effector T cells exhibit impaired effector functions in chronic lymphocytic leukemia

Author

Bozorgmehr, Najmeh, primary, Okoye, Isobel, additional, Oyegbami, Olaide, additional, Xu, Lai, additional, Fontaine, Amelie, additional, Cox-Kennett, Nanette, additional, Larratt, Loree M, additional, Hnatiuk, Mark, additional, Fagarasanu, Andrei, additional, Brandwein, Joseph, additional, Peters, Anthea C, additional, and Elahi, Shokrollah, additional

Published
2021
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18. Pretreatment with ibrutinib reduces cytokine secretion and limits the risk of obinutuzumab-induced infusion-related reactions in patients with CLL: analysis from the iLLUMINATE study

Author

Greil, Richard, Tedeschi, Alessandra, Moreno, Carol, Anz, Bertrand, Larratt, Loree, Simkovic, Martin, Gill, Devinder, Gribben, John G., Flinn, Ian W., Wang, Zhengyuan, Cheung, Leo W. K., Nguyen, Aaron N., Zhou, Cathy, Styles, Lori, Demirkan, Fatih, and Universitat Autònoma de Barcelona

Subjects
Adult, Male, medicine.medical_specialty, medicine.medical_treatment, Chronic lymphocytic leukemia, Premedication, Infusion-related reactions, Antibodies, Monoclonal, Humanized, Gastroenterology, Proinflammatory cytokine, chemistry.chemical_compound, Piperidines, Obinutuzumab, Internal medicine, parasitic diseases, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Prospective Studies, Infusions, Intravenous, Aged, Aged, 80 and over, Hematology, Chlorambucil, business.industry, Adenine, Ibrutinib, General Medicine, Middle Aged, medicine.disease, Leukemia, Lymphocytic, Chronic, B-Cell, Cytokine, chemistry, population characteristics, Cytokines, Cytokine secretion, Female, Original Article, business, medicine.drug
Abstract

Anti-CD20 antibody treatments, such as obinutuzumab, have been associated with infusion-related reactions (IRRs). In the phase 3 iLLUMINATE study of ibrutinib-obinutuzumab versus chlorambucil-obinutuzumab in first-line chronic lymphocytic leukemia/small lymphocytic lymphoma, IRRs were substantially reduced with ibrutinib-obinutuzumab versus chlorambucil-obinutuzumab. We prospectively analyzed inflammatory cytokines to evaluate the impact of ibrutinib on circulating cytokine levels following obinutuzumab infusion. In iLLUMINATE, ibrutinib or chlorambucil was given approximately 30–120 min before the first obinutuzumab infusion. Cytokines evaluated were IFNγ, IL-6, IL-8, IL-10, IL-18, MCP-1, MIP-1α, MIP-1β, and TNFα. Changes in peak cytokine levels from baseline (immediately before obinutuzumab) to post-obinutuzumab infusion were compared between arms and between patients with versus without IRRs using Wilcoxon rank sum test. Of 228 treated patients, 95 on ibrutinib-obinutuzumab (15 with IRRs, 80 without) and 88 on chlorambucil-obinutuzumab (45 with IRRs, 43 without) with cytokine data were included. Irrespective of IRR occurrence, median increase in cytokines was lower with ibrutinib-obinutuzumab versus chlorambucil-obinutuzumab for all cytokines (P < 0.01) except MIP-1β. Across treatment arms, post-obinutuzumab median increase in all cytokines except MIP-1β was greater in patients with versus without IRRs (P < 0.001). IL-6 and IL-8 elevations were associated with IRRs in both treatment arms. Among patients with IRRs, those receiving ibrutinib-obinutuzumab had lower post-obinutuzumab increases in IL-6, IL-8, IL-10, and MCP-1 (P < 0.04) than patients receiving chlorambucil-obinutuzumab. For patients in the ibrutinib-treatment arm, we observed a reduction in both the rate of clinically apparent IRRs and the levels of IRR-related cytokines and chemokines. This observation supports an immunomodulatory mechanism of action for ibrutinib. Clinical Trial Registration: NCT02264574

Published
2020

20. A Non-Inferiority Trial of Perioperative Eltrombopag or Intravenous Immune Globulin for Immune Thrombocytopenia

Author

Arnold, Donald, primary, Tinmouth, Alan, additional, Heddle, Nancy M., additional, Cook, Richard J., additional, Hsia, Cyrus, additional, Blostein, Mark, additional, Jamula, Erin, additional, Sholzberg, Michelle, additional, Lin, Yulia, additional, Kassis, Jeannine, additional, Larratt, Loree, additional, Amini, Sufia, additional, Schipperus, Martin, additional, Lim, Wendy, additional, Vishnu, Prakash, additional, Warner, Margaret, additional, Carruthers, Julie, additional, Li, Na, additional, Lane, Shannon, additional, and Kelton, John G., additional

Published
2020
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21. Clinical Characteristics and Outcome of Canadian Patients Diagnosed With Atypical Hemolytic Uremic Syndrome

Author

Lapeyraque, Anne-Laure, primary, Bitzan, Martin, additional, Al-Dakkak, Imad, additional, Francis, Mira, additional, Huang, Shih-Han S., additional, Kaprielian, Roger, additional, Larratt, Loree, additional, Pavenski, Katerina, additional, Ribic, Christine, additional, Tosikyan, Axel, additional, Licht, Christoph, additional, and Philibert, David, additional

Published
2020
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22. Perioperative Eltrombopag or Intravenous Immune Globulin for Patients with Immune Thrombocytopenia: A Multicenter Randomized Trial

Author

Arnold, Donald M., primary, Heddle, Nancy, primary, Cook, Richard, primary, Hsia, Cyrus C., primary, Blostein, Mark, primary, Jamula, Erin, primary, Sholzberg, Michelle, primary, Lin, Yulia, primary, Kassis, Jeannine, primary, Larratt, Loree, primary, Amini, Sufia, primary, Schipperus, Martin R., primary, Lim, Wendy, primary, Vishnu, Prakash, primary, Warner, Margaret, primary, Carruthers, Julie, primary, Lane, Shannon J, primary, Li, Na, primary, and Kelton, John G., primary

Published
2019
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23. Peri-Operative Eltrombopag or Immune Globulin for Patients with Immune Thrombocytopaenia (The Bridging ITP Trial): Methods and Rationale

Author

Arnold, Donald, additional, Jamula, Erin, additional, Heddle, Nancy, additional, Cook, Richard, additional, Hsia, Cyrus, additional, Sholzberg, Michelle, additional, Lin, Yulia, additional, Kassis, Jeannine, additional, Blostein, Mark, additional, Larratt, Loree, additional, Amini, Sufia, additional, Schipperus, Martin, additional, Carruthers, Julie, additional, Lane, Shannon, additional, Li, Na, additional, and Kelton, John, additional

Published
2019
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24. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial

Author

Moreno, Carol, primary, Greil, Richard, additional, Demirkan, Fatih, additional, Tedeschi, Alessandra, additional, Anz, Bertrand, additional, Larratt, Loree, additional, Simkovic, Martin, additional, Samoilova, Olga, additional, Novak, Jan, additional, Ben-Yehuda, Dina, additional, Strugov, Vladimir, additional, Gill, Devinder, additional, Gribben, John G, additional, Hsu, Emily, additional, Lih, Chih-Jian, additional, Zhou, Cathy, additional, Clow, Fong, additional, James, Danelle F, additional, Styles, Lori, additional, and Flinn, Ian W, additional

Published
2019
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25. A Phase 3 Study of Ravulizumab (ALXN1210) Versus Eculizumab in Adults with Paroxysmal Nocturnal Hemoglobinuria Naive to Complement Inhibitors: Results of a Subgroup Analysis with Patients Stratified By Baseline Hemolysis Level, Transfusion History, and Demographics

Author

Weitz, Ilene C., primary, Kulagin, Aleksandr, additional, Nakao, Shinji, additional, Piatek, Caroline I., additional, Szer, Jeffrey, additional, Rottinghaus, Scott T., additional, Volles, Lori, additional, Damokosh, Andrew I., additional, Aguzzi, Rasha, additional, Larratt, Loree, additional, and Risitano, Antonio M., additional

Published
2018
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27. Ibrutinib + Obinutuzumab Versus Chlorambucil + Obinutuzumab As First-Line Treatment in Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL): Results from Phase 3 iLLUMINATE

Author

Moreno, Carol, primary, Greil, Richard, additional, Demirkan, Fatih, additional, Tedeschi, Alessandra, additional, Anz, Bertrand, additional, Larratt, Loree, additional, Simkovic, Martin, additional, Samoilova, Olga, additional, Novak, Jan, additional, Ben-Yehuda, Dina, additional, Strugov, Vladimir, additional, Gill, Devinder, additional, Gribben, John G., additional, Hsu, Emily, additional, Zhou, Cathy, additional, Clow, Fong, additional, James, Danelle F., additional, Styles, Lori, additional, and Flinn, Ian W., additional

Published
2018
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28. How we treat paroxysmal nocturnal hemoglobinuria: A consensus statement of the Canadian PNH Network and review of the national registry

Author

Patriquin, Christopher J., primary, Kiss, Thomas, additional, Caplan, Stephen, additional, Chin‐Yee, Ian, additional, Grewal, Kuljit, additional, Grossman, Jennifer, additional, Larratt, Loree, additional, Marceau, Daniele, additional, Nevill, Tom, additional, Sutherland, D. Robert, additional, Wells, Richard A., additional, and Leber, Brian, additional

Published
2018
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30. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia

Author

WEINKOVE, Robert, PRISTUPA, Alexander, KASYCH, Muzhdaba, YAGCI, Munci, MARCO, Jose Antonio Garcia, Vural, Filiz, Kaynar, Leylagül, BURGER, J. A., ROBAK, T., TEDESCHI, A., Barr, P. M., Owen, C., GHIA, P., Bairey, O., HILLMEN, P., BARTLETT, N. L., LI, J., SIMPSON, D., GROSICKI, S., HAMBLIN, Michael, ATKINS, James, BARRIENTOS, Jaqueline, DUNCOMBE, Andrew, GASIC, Slavisa, HOU, Jing-Zhou, KINGSLEY, Edwin, SHADMAN, Mazyar, BADOUX, Xavier, GILL, Devinder, OPAT, Stephen, BRON, Dominique, VAN DEN NESTE, Eric, JING, Hongmei, ZHU, Jun, VANDENBERGHE, Elisabeth, TADMOR, Tamar, CORTELEZZI, Agostino, GANLY, Peter, PLUTA, Andrzej, DEVEREUX, S., MCCARTHY, H., COUTRE, S., QUACH, H., GAIDANO, G., MASLYAK, Z., STEVENS, D. A., JANSSENS, A., OFFNER, F., MAYER, J., O'DWYER, M., HELLMANN, A., Schuh, A., SIDDIQI, T., POLLIACK, A., TAM, C. S., SURI, D., CHENG, M., CLOW, F., STYLES, L., JAMES, D. F., KIPPS, T. J., TIRUMALI, Nagendra, QUACKENBUSH, Robert, FEGAN, Christopher, KEATING, Michael, JEN, Jie, JINDRA, Pavel, SIMKOVIC, Martin, BRAESTER, Andrei, RUCHLEMER, Rosa, FOA, Roberto, SEMENZATO, Gianpietro, HAWKINS, Timothy, ATANASIO, Carolina Moreno, Demirkan, Fatih, PYLYPENKO, Halyna, FOX, Christopher, THIRMAN, Michael, CAMPBELL, Philip, COUGHLIN, Paul, HARRUP, Rosemary, KUSS, Bryone, TURNER, Paul, WU, Ka Lung, LARRATT, Loree, FINEMAN, Riva, MARASCA, Roberto, ZINZANI, Pier Luigi, CORBETT, Gillian, ABRISQUETA, Pau, DELGADO, Julio, GONZALEZ-BARCA, Eva, DE OTEYZA, Jaime Perez, ARSLAND, Onder, KAPLAN, Polina, OLIYNYK, Hanna, Burger, Jan A, Tedeschi, Alessandra, Barr, Paul M, Robak, Tadeusz, Owen, Carolyn, Ghia, Paolo, Bairey, Osnat, Hillmen, Peter, Bartlett, Nancy L, Li, Jianyong, Simpson, David, Grosicki, Sebastian, Devereux, Stephen, Mccarthy, Helen, Coutre, Steven, Quach, Hang, Gaidano, Gianluca, Maslyak, Zvenyslava, Stevens, Don A, Janssens, Ann, Offner, Fritz, Mayer, Jiří, O'Dwyer, Michael, Hellmann, Andrzej, Schuh, Anna, Siddiqi, Tanya, Polliack, Aaron, Tam, Constantine S, Suri, Deepali, Cheng, Mei, Clow, Fong, Styles, Lori, James, Danelle F, Kipps, Thomas J, M.D., Ph.D., for the RESONATE-2 Investigators [.., Pier Luigi Zinzani, Antonietta Tedeschi, ], Burger, Ja, Tedeschi, A, Barr, Pm, Robak, T, Owen, C, Ghia, P, Bairey, O, Hillmen, P, Bartlett, Nl, Li, J, Simpson, D, Grosicki, S, Devereux, S, Mccarthy, H, Coutre, S, Quach, H, Gaidano, G, Maslyak, Z, Stevens, Da, Janssens, A, Offner, F, Mayer, J, O'Dwyer, M, Hellmann, A, Schuh, A, Siddiqi, T, Polliack, A, Tam, C, Suri, D, Cheng, M, Clow, F, Styles, L, James, Df, Kipps, Tj, and for the RESONATE-2, Investigators

Subjects
Male, pci-32765, previously untreated patients, Lymphoma, Gastroenterology, Medical and Health Sciences, Medicaments antineoplàstics, Antineoplastic Agent, chemistry.chemical_compound, 0302 clinical medicine, chlorambucil, Piperidines, Obinutuzumab, immune system diseases, hemic and lymphatic diseases, Antineoplastic agents, Chronic, Fatigue, Cancer, cll, 0303 health sciences, Leukemia, Medicine (all), Hazard ratio, tyrosine kinase, Leucèmia, General Medicine, Hematology, Duvelisib, Lymphocytic, 3. Good health, Fludarabine, Aged, Antineoplastic Agents, Chlorambucil, Diarrhea, Disease-Free Survival, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Neutropenia, Pyrazoles, Pyrimidines, Survival Analysis, 030220 oncology & carcinogenesis, Ibrutinib, 6.1 Pharmaceuticals, RESONATE-2 Investigators, Acalabrutinib, medicine.drug, Human, medicine.medical_specialty, Cèl·lules B, Clinical Trials and Supportive Activities, open-label, 03 medical and health sciences, Rare Diseases, Clinical Research, Internal medicine, General & Internal Medicine, medicine, cancer, Survival rate, 030304 developmental biology, B cells, business.industry, Adenine, B-Cell, fludarabine, Evaluation of treatments and therapeutic interventions, phase-3 trial, Pirimidines, Orphan Drug, chemistry, Pyrimidine, Immunology, Pyrazole, cyclophosphamide, business
Abstract

Chronic lymphocytic leukemia (CLL) primarily affects older persons who often have coexisting conditions in addition to disease-related immunosuppression and myelosuppression. We conducted an international, open-label, randomized phase 3 trial to compare two oral agents, ibrutinib and chlorambucil, in previously untreated older patients with CLL or small lymphocytic lymphoma. Background Chronic lymphocytic leukemia (CLL) primarily affects older persons who often have coexisting conditions in addition to disease-related immunosuppression and myelosuppression. We conducted an international, open-label, randomized phase 3 trial to compare two oral agents, ibrutinib and chlorambucil, in previously untreated older patients with CLL or small lymphocytic lymphoma. METHODS We randomly assigned 269 previously untreated patients who were 65 years of age or older and had CLL or small lymphocytic lymphoma to receive ibrutinib or chlorambucil. The primary end point was progression-free survival as assessed by an independent review committee. RESULTS The median age of the patients was 73 years. During a median follow-up period of 18.4 months, ibrutinib resulted in significantly longer progression-free survival than did chlorambucil (median, not reached vs. 18.9 months), with a risk of progression or death that was 84% lower with ibrutinib than that with chlorambucil (hazard ratio, 0.16; P

Published
2015

31. A Distributed International Patient Data Registry for Hairy Cell Leukemia

Author

Andritsos, Leslie A., primary, Grever, Michael R., additional, Anghelina, Mirela, additional, Dearden, Claire E, additional, Else, Monica, additional, Blachly, James S., additional, Lele, Omkar, additional, Ravandi, Farhad, additional, Zent, Clive S, additional, Johnston, James B., additional, Banerji, Versha, additional, Forconi, Francesco, additional, Ho, Anthony D., additional, Zenz, Thorsten, additional, Dietrich, Sascha, additional, Demeter, Judit, additional, Barrientos, Jacqueline C., additional, Burger, Jan A., additional, Call, Timothy G., additional, Chiorazzi, Nicholas, additional, DeAngelo, Daniel J., additional, Delgado, Julio, additional, Fagarasanu, Andrei, additional, Falini, Brunangelo, additional, Gozzetti, Alessandro, additional, Jones, Jeffrey, additional, Juliusson, Gunnar, additional, Kraut, Eric H., additional, Kreitman, Robert J., additional, Larratt, Loree, additional, Lauria, Francesco, additional, Lozanski, Gerard, additional, Montserrat, Emili, additional, Parikh, Sameer A., additional, Park, Jae H., additional, Polliack, Aaron, additional, Quest, Graeme R., additional, Rai, Kanti R., additional, Robak, Tadeusz, additional, Saven, Alan, additional, Tadmor, Tamar, additional, Tallman, Martin S., additional, Tam, Constantine S., additional, Tiacci, Enrico, additional, Troussard, Xavier, additional, Abdel-Wahab, Omar, additional, Zinzani, Pier Luigi, additional, Heckler, Christopher, additional, and Payne, Philip R.O., additional

Published
2016
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32. How we treat paroxysmal nocturnal hemoglobinuria: A consensus statement of the Canadian PNH Network and review of the national registry.

Author

Patriquin, Christopher J., Kiss, Thomas, Caplan, Stephen, Chin‐Yee, Ian, Grewal, Kuljit, Grossman, Jennifer, Larratt, Loree, Marceau, Daniele, Nevill, Tom, Sutherland, D. Robert, Wells, Richard A., and Leber, Brian

Subjects
PAROXYSMAL hemoglobinuria, BLOOD disease treatment, HEMATOPOIETIC stem cells, ECULIZUMAB, HEMOLYSIS & hemolysins
Abstract

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare hematologic disease characterized by intravascular hemolysis, thrombophilia, and marrow failure. Its phenotype is due to absent or reduced expression of GPI‐linked complement regulators and subsequent sensitivity of hematopoietic cells to complement‐mediated damage and lysis. Introduction of the terminal complement inhibitor eculizumab drastically improved outcomes in PNH patients; however, despite this improvement, there remain several challenges faced by PNH patients and physicians who care for them. One of the most important is increasing awareness of the heterogeneity with which patients can present, which can lead to significant delays in recognition. Data from the Canadian PNH Registry are presented to demonstrate the variety of presenting symptoms. In Canada, geography precludes consolidation of care to just a few centers, so management is distributed across academic hospitals, linked together as the Canadian PNH Network. The Network over the last several years has developed educational programs and clinical checklists and has worked to standardize access to diagnostics across the country. Herein, we address some of the common diagnostic and therapeutic challenges faced by PNH physicians and give our recommendations. Gaps in knowledge are also addressed, and where appropriate, consensus opinion is provided. [ABSTRACT FROM AUTHOR]

Published
2019
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33. The fludarabine, cytarabine, and granulocyte colony-stimulating factor (FLAG) chemotherapy regimen is an alternative to anthracycline-based therapy for the treatment of acute myeloid leukemia for patients with pre-existing cardiac disease

Author

Saini, Lalit, primary, Brandwein, Joseph, additional, Turner, Robert, additional, Larratt, Loree, additional, Hamilton, Marlene, additional, Peters, Anthea, additional, Wu, Cynthia, additional, Zhu, Nancy, additional, Patterson, Jeffery M., additional, Bolster, Lauren, additional, Mant, Michael, additional, Ritchie, Bruce, additional, Liew, Elena, additional, Ghosh, Sunita, additional, and Sandhu, Irwindeep, additional

Published
2016
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34. Antithymocyte Globulin at Clinically Relevant Concentration Kills Leukemic Blasts

Author

Dabas, Rosy, primary, Lee, Rachelle, additional, Servito, Maria Theresa, additional, Khan, Poonam Dharmani, additional, Modi, Monica, additional, Slyke, Tiffany Van, additional, Luider, Joanne, additional, Durand, Caylib, additional, Larratt, Loree, additional, Brandwein, Joseph, additional, Daly, Andrew, additional, Khan, Faisal M, additional, and Storek, Jan, additional

Published
2015
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36. The FLAG Chemotherapy Regimen Is an Alternative to Anthracycline Based Therapy for the Treatment of Acute Myeloid Leukemia for Patients with Multiple Co-Morbidities or Preexisting Cardiac Disease

Author

Saini, Lalit, primary, Turner, Robert, additional, Larratt, Loree, additional, Brandwein, Joseph, additional, Hamilton, Marlene Ann, additional, Peters, Anthea, additional, Wu, Cynthia M., additional, Zhu, Nancy, additional, Patterson, Jeffery M., additional, Bolster, Lauren, additional, Mant, Michael, additional, Ritchie, Bruce, additional, Liew, Elena, additional, Mirza, Imran, additional, Quest, Graeme R., additional, Gosh, Sunita, additional, and Sandhu, Irwindeep, additional

Published
2014
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37. Bone Marrow Aspirates Alone without a Trephine Biopsy May be Insufficient for the Detection of Residual Leukemia Following Intensive Chemotherapy for the Treatment of Acute Myeloid Leukemia

Author

Saini, Lalit, primary, Turner, Robert, additional, Larratt, Loree, additional, Brandwein, Joseph, additional, Hamilton, Marlene Ann, additional, Peters, Anthea, additional, Wu, Cynthia M, additional, Zhu, Nancy, additional, Patterson, Jeffery M., additional, Bolster, Lauren, additional, Mant, Michael, additional, Ritchie, Bruce, additional, Liew, Elena, additional, Mirza, Imran, additional, Quest, Graeme R., additional, Nahirniak, Susan, additional, Gosh, Sunita, additional, and Sandhu, Irwindeep, additional

Published
2014
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39. Analysis of Baseline Clinical Characteristics and Disease Burden in Patients Enrolled in the International Paroxysmal Nocturnal Hemoglobinuria Registry

Author

Schrezenmeier, Hubert, Maciejewski, Jaroslaw P., Roeth, Alexander, Araten, David J., Kanakura, Yuzuru, Larratt, Loree, Shammo, Jamile M., Wilson, Amanda, Shayan, Gilda, and Hillmen, Peter

Abstract

Background/Objective:Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired, potentially life-threatening hematologic disorder characterized by chronic uncontrolled intravascular hemolysis, thrombosis, end organ damage, and impaired quality of life (QoL) and survival. The International PNH Registry (NCT01374360) is an ongoing, global observational study to evaluate the safety profile of eculizumab and to characterize the burden and progression of PNH including clinical outcomes, morbidity, and mortality irrespective of treatment. The objective of this analysis was to characterize the demographic and clinical characteristics, disease-associated morbidities, PNH symptoms, and health-related QoL of the largest cohort of PNH patients enrolled in the Registry.

Published
2017
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40. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia

Author

Philippe Rousselot, Shira Dinner, Robert J. Kreitman, Bjørn Tore Gjertsen, Monica Bocchia, Andrzej Hellmann, Lionel Karlin, Fritz Offner, Philipp le Coutre, Gary J. Schiller, Agostino Cortelezzi, Xavier Troussard, Nai Shun Yao, Mirjana Gotic, Shannon Marshall, Tamar Tadmor, Michael Doubek, Ira Pastan, Wyndham H. Wilson, Kemal Balic, Gail J. Roboz, Sascha Dietrich, Peng He, Marco Gobbi, Ronan T. Swords, Francis J. Giles, Loree Larratt, Tadeusz Robak, Dimitri Breems, Tanya Siddiqi, Nathan Standifer, Giuseppe Saglio, Larry Bacon, Douglas E. Gladstone, Krimo Bouabdallah, Pier Luigi Zinzani, Farhad Ravandi, Julio Delgado, Mathias J. Rummel, Cecilia Arana Yi, Frédéric Maloisel, Claire Dearden, Stéphane Leprêtre, National Cancer Institute [Bethesda] (NCI-NIH), National Institutes of Health [Bethesda] (NIH), Royal Marsden NHS Foundation Trust, University of Bologna, Barcelona Centre for International Health Research, Hospital Clinic (CRESIB), Universitat de Barcelona (UB), Service d’Hématologie [Centre Hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Medical University of Łódź (MUL), Johns Hopkins University (JHU), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Universität Heidelberg [Heidelberg], Clinical Center of Serbia (KCS), University of Alberta, Universiteit Gent = Ghent University [Belgium] (UGENT), David Geffen School of Medicine [Los Angeles], University of California [Los Angeles] (UCLA), University of California-University of California, University of Miami [Coral Gables], St James's University Hospital, Leeds Teaching Hospitals NHS Trust, Università degli Studi di Siena = University of Siena (UNISI), CHU Bordeaux [Bordeaux], Ziekenhuis Netwerk Antwerpen (ZNA), Università degli Studi di Milano [Milano] (UNIMI), Northwestern University Feinberg School of Medicine, Faculty of Science [Brno] (SCI / MUNI), Masaryk University [Brno] (MUNI), Haukeland University Hospital, University of Bergen (UiB), Ospedale Policlinico San Martino [Genoa], Medical University of Gdańsk, Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Clinique Sainte Anne [Strasbourg], MD Anderson Cancer Center [Houston], The University of Texas Health Science Center at Houston (UTHealth), Infection et inflammation (2I), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Justus-Liebig-Universität Gießen (JLU), City of Hope National Medical Center, Bnai Zion Medical Center [Israël], Hôpital Côte de Nacre [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), The University of New Mexico [Albuquerque], University of Turin, New York Presbyterian Hospital, MedImmune, University of Bologna/Università di Bologna, Universiteit Gent = Ghent University (UGENT), University of California (UC)-University of California (UC), Università degli Studi di Milano = University of Milan (UNIMI), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Justus-Liebig-Universität Gießen = Justus Liebig University (JLU), Università degli studi di Torino = University of Turin (UNITO), Normandie, Université, Kreitman, Robert J, Dearden, Claire, Zinzani, Pier Luigi, Delgado, Julio, Karlin, Lionel, Robak, Tadeusz, Gladstone, Douglas E, le Coutre, Philipp, Dietrich, Sascha, Gotic, Mirjana, Larratt, Loree, Offner, Fritz, Schiller, Gary, Swords, Ronan, Bacon, Larry, Bocchia, Monica, Bouabdallah, Krimo, Breems, Dimitri A, Cortelezzi, Agostino, Dinner, Shira, Doubek, Michael, Gjertsen, Bjorn Tore, Gobbi, Marco, Hellmann, Andrzej, Lepretre, Stephane, Maloisel, Frederic, Ravandi, Farhad, Rousselot, Philippe, Rummel, Mathia, Siddiqi, Tanya, Tadmor, Tamar, Troussard, Xavier, Yi, Cecilia Arana, Saglio, Giuseppe, Roboz, Gail J, Balic, Kemal, Standifer, Nathan, He, Peng, Marshall, Shannon, Wilson, Wyndham, Pastan, Ira, Yao, Nai-Shun, and Giles, Francis

Subjects
0301 basic medicine, Male, [SDV.MHEP.HEM] Life Sciences [q-bio]/Human health and pathology/Hematology, Cancer Research, ERADICATION, Peripheral edema, Salvage therapy, Gastroenterology, Moxetumomab pasudotox, 0302 clinical medicine, Medicine and Health Sciences, Medicine, Aged, 80 and over, Leukemia, Hairy Cell, Remission Induction, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Hematology, Middle Aged, Prognosis, 3. Good health, Survival Rate, Tolerability, Oncology, 030220 oncology & carcinogenesis, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Female, Moxetumomab pasudotox hairy cell leukemia, medicine.symptom, Adult, medicine.medical_specialty, Bacterial Toxins, Exotoxins, MINIMAL RESIDUAL DISEASE, Antineoplastic Agents, [SDV.CAN]Life Sciences [q-bio]/Cancer, DIAGNOSIS, Article, 03 medical and health sciences, Refractory, [SDV.CAN] Life Sciences [q-bio]/Cancer, Internal medicine, Humans, Hairy cell leukemia, RITUXIMAB, IMMUNOHISTOCHEMISTRY, Survival rate, TERM-FOLLOW-UP, Aged, Salvage Therapy, CLADRIBINE, business.industry, medicine.disease, EFFICACY, Minimal residual disease, 030104 developmental biology, ANTIBODY, Drug Resistance, Neoplasm, PATTERNS, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Neoplasm Recurrence, Local, business, Follow-Up Studies
Abstract

International audience; This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/ refractory HCL who had ≥2 prior systemic therapies, including ≥1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 µg/kg intravenously on days 1, 3, and 5 every 28 days for ≤6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.

Published
2018

41. Consensus guidelines for the diagnosis and management of patients with classic hairy cell leukemia

Author

Aaron Polliack, Tamar Tadmor, Brunangelo Falini, James B. Johnston, Judit Demeter, Xavier Troussard, Jae-Hyun Park, Daniel Catovsky, Omar Abdel-Wahab, Alessandro Gozzetti, Versha Banerji, Alan Saven, Monica Else, John F. Seymour, James S. Blachly, Robert J. Kreitman, Constantine S. Tam, Clive S. Zent, Francesco Lauria, Kanti R. Rai, Emili Montserrat, Francesco Forconi, Michael R. Grever, Leslie A. Andritsos, Jacqueline C. Barrientos, Martin S. Tallman, Claire Dearden, Graeme R. Quest, Anthony D. Ho, Eric H. Kraut, Loree Larratt, Gunnar Juliusson, Enrico Tiacci, Sameer A. Parikh, Tadeusz Robak, Timothy G. Call, Pier Luigi Zinzani, Farhad Ravandi, Jeffrey A. Jones, Gerard Lozanski, Thorsten Zenz, Normandie, Université, Ohio State University [Columbus] (OSU), Memorial Sloane Kettering Cancer Center [New York], University of Manitoba [Winnipeg], Hofstra University [Hempstead], Mayo Clinic [Rochester], The institute of cancer research [London], Royal Marsden NHS Foundation Trust, Semmelweis University of Medicine [Budapest], University of Southampton, Azienda Ospedaliera Universitaria Senese, University of Heidelberg, Medical Faculty, Skane University Hospital [Lund], National Institutes of Health [Bethesda] (NIH), University of Alberta, University of Barcelona, The Hebrew University Hadassah Medical School, University Health Network, The University of Texas M.D. Anderson Cancer Center [Houston], Medical University of Łódź (MUL), Scripps Clinic [San Diego, CA, USA], University of Melbourne, Technion - Israel Institute of Technology [Haifa], Università degli Studi di Perugia = University of Perugia (UNIPG), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Rochester Medical Center (URMC), German Cancer Research Center - Deutsches Krebsforschungszentrum [Heidelberg] (DKFZ), University of Bologna/Università di Bologna, Università degli Studi di Perugia (UNIPG), University of Bologna, Grever, Michael R, Abdel-Wahab, Omar, Andritsos, Leslie A., Banerji, Versha, Barrientos, Jacqueline, Blachly, James S., Call, Timothy G., Catovsky, Daniel, Dearden, Claire, Demeter, Judit, Else, Monica, Forconi, Francesco, Gozzetti, Alessandro, Ho, Anthony D., Johnston, James B., Jones, Jeffrey, Juliusson, Gunnar, Kraut, Eric, Kreitman, Robert J., Larratt, Loree, Lauria, Francesco, Lozanski, Gerard, Montserrat, Emili, Parikh, Sameer A., Park, Jae H., Polliack, Aaron, Quest, Graeme R., Rai, Kanti R., Ravandi, Farhad, Robak, Tadeusz, Saven, Alan, Seymour, John F., Tadmor, Tamar, Tallman, Martin S., Tam, Constantine, Tiacci, Enrico, Troussard, Xavier, Zent, Clive S., Zenz, Thorsten, Zinzani, Pier Luigi, and Falini, Brunangelo

Subjects
medicine.medical_specialty, Neoplasm, Residual, Hairy Cell, Immunology, Antineoplastic Agents, Review Article, Disease, Biochemistry, [SDU] Sciences of the Universe [physics], 03 medical and health sciences, 0302 clinical medicine, Quality of life (healthcare), medicine, Humans, Hairy cell leukemia, Disease management (health), Intensive care medicine, Leukemia, Hairy Cell, Leukemia, business.industry, Risk of infection, Disease Management, Hematology, Cell Biology, Cladribine, Neoplasm Recurrence, Local, Pentostatin, Treatment Outcome, medicine.disease, Minimal residual disease, 3. Good health, Clinical trial, Clinical research, Neoplasm Recurrence, Local, [SDU]Sciences of the Universe [physics], 030220 oncology & carcinogenesis, Residual, Neoplasm, business, 030215 immunology
Abstract

Hairy cell leukemia is an uncommon hematologic malignancy characterized by pancytopenia and marked susceptibility to infection. Tremendous progress in the management of patients with this disease has resulted in high response rates and improved survival, yet relapse and an appropriate approach to re-treatment present continuing areas for research. The disease and its effective treatment are associated with immunosuppression. Because more patients are being treated with alternative programs, comparison of results will require general agreement on definitions of response, relapse, and methods of determining minimal residual disease. The development of internationally accepted, reproducible criteria is of paramount importance in evaluating and comparing clinical trials to provide optimal care. Despite the success achieved in managing these patients, continued participation in available clinical trials in the first-line and particularly in the relapse setting is highly recommended. The Hairy Cell Leukemia Foundation convened an international conference to provide common definitions and structure to guide current management. There is substantial opportunity for continued research in this disease. In addition to the importance of optimizing the prevention and management of the serious risk of infection, organized evaluations of minimal residual disease and treatment at relapse offer ample opportunities for clinical research. Finally, a scholarly evaluation of quality of life in the increasing number of survivors of this now manageable chronic illness merits further study. The development of consensus guidelines for this disease offers a framework for continued enhancement of the outcome for patients.

Published
2017

42. Expanded antigen-experienced CD160 + CD8 + effector T cells exhibit impaired effector functions in chronic lymphocytic leukemia.

Author

Bozorgmehr N, Okoye I, Oyegbami O, Xu L, Fontaine A, Cox-Kennett N, Larratt LM, Hnatiuk M, Fagarasanu A, Brandwein J, Peters AC, and Elahi S

Subjects
Aged, Aged, 80 and over, Case-Control Studies, Cell Proliferation, Cells, Cultured, Cytokines blood, Extracellular Vesicles immunology, Extracellular Vesicles metabolism, Female, GPI-Linked Proteins metabolism, Humans, Leukemia, Lymphocytic, Chronic, B-Cell immunology, Lymphocyte Activation, Lymphocytes, Tumor-Infiltrating immunology, Male, Middle Aged, Phenotype, Receptors, Antigen, T-Cell metabolism, Signal Transduction, T-Lymphocytes immunology, Antigens, CD metabolism, Leukemia, Lymphocytic, Chronic, B-Cell metabolism, Lymphocytes, Tumor-Infiltrating metabolism, Receptors, Immunologic metabolism, T-Lymphocytes metabolism
Abstract

Background: T cell exhaustion compromises antitumor immunity, and a sustained elevation of co-inhibitory receptors is a hallmark of T cell exhaustion in solid tumors. Similarly, upregulation of co-inhibitory receptors has been reported in T cells in hematological cancers such as chronic lymphocytic leukemia (CLL). However, the role of CD160, a glycosylphosphatidylinositol-anchored protein, as one of these co-inhibitory receptors has been contradictory in T cell function. Therefore, we decided to elucidate how CD160 expression and/or co-expression with other co-inhibitory receptors influence T cell effector functions in patients with CLL., Methods: We studied 56 patients with CLL and 25 age-matched and sex-matched healthy controls in this study. The expression of different co-inhibitory receptors was analyzed in T cells obtained from the peripheral blood or the bone marrow. Also, we quantified the properties of extracellular vesicles (EVs) in the plasma of patients with CLL versus healthy controls. Finally, we measured 29 different cytokines, chemokines or other biomarkers in the plasma specimens of patients with CLL and healthy controls., Results: We found that CD160 was the most upregulated co-inhibitory receptor in patients with CLL. Its expression was associated with an exhausted T cell phenotype. CD160 + CD8 + T cells were highly antigen-experienced/effector T cells, while CD160 + CD4 + T cells were more heterogeneous. In particular, we identified EVs as a source of CD160 in the plasma of patients with CLL that can be taken up by T cells. Moreover, we observed a dominantly proinflammatory cytokine profile in the plasma of patients with CLL. In particular, interleukin-16 (IL-16) was highly elevated and correlated with the advanced clinical stage (Rai). Furthermore, we observed that the incubation of T cells with IL-16 results in the upregulation of CD160., Conclusions: Our study provides a novel insight into the influence of CD160 expression/co-expression with other co-inhibitory receptors in T cell effector functions in patients with CLL. Besides, IL-16-mediated upregulation of CD160 expression in T cells highlights the importance of IL-16/CD160 as potential immunotherapy targets in patients with CLL. Therefore, our findings propose a significant role for CD160 in T cell exhaustion in patients with CLL., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2021
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