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Duvelisib for the treatment of chronic lymphocytic leukemia.

Anna Maria Frustaci, Alessandra Tedeschi, Marina Deodato, Giulia Zamprogna, Roberto Cairoli, Marco Montillo,

Introduction: Duvelisib, a first in class, oral, dual PI3 k-delta/gamma inhibitor recently received FDA approval for previously treated CLL (chronic lymphocytic leukemia)/SLL (small lymphocytic lymphoma) and follicular lymphoma. Data coming from the phase III 'DUO' trial, in fact, showed a superior progression-free survival (PFS) in CLL patients treated with duvelisib compared ... Read more >>

Expert Opin Pharmacother (Expert opinion on pharmacotherapy)
[2020, :1-11]

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A five-year follow-up of untreated patients with chronic lymphocytic leukaemia treated with ofatumumab and chlorambucil: final analysis of the Complement 1 phase 3 trial.

Fritz Offner, Tadeusz Robak, Ann Janssens, K Govind Babu, Janusz Kloczko, Sebastian Grosicki, Jiri Mayer, Panagiotis Panagiotidis, Anna Schuh, Andrew Pettitt, Marco Montillo, Olena Werner, Ghislaine Vincent, Sadhvi Khanna, Peter Hillmen,

The Complement 1 trial investigated the efficacy and safety of ofatumumab + chlorambucil with chlorambucil monotherapy in patients with previously untreated chronic lymphocytic leukaemia (CLL). On long-term follow-up in the chemoimmunotherapy arm vs. the chemotherapy arm there was an estimated 12% (not significant) and 39% risk reduction in overall survival and progression-free ... Read more >>

Br. J. Haematol. (British journal of haematology)
[2020, :]

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Five-year survival follow-up of a phase III randomised trial comparing ofatumumab versus physicians' choice for bulky fludarabine-refractory chronic lymphocytic leukaemia: a short report.

Udvardy Miklos, Vladimir Strugov, Catharina Lewerin, Sebastian Grosicki, Grzegorz Mazur, Michael Steurer, Marco Montillo, Irina Kryachok, Jan M Middeke, Grygoriy Rekhtman, Tommaso Stefanelli, Ghislaine Vincent, Sameera Govindaraju, Anders Österborg,

In 2014, an interim analysis of a phase 3 study was performed to evaluate the effectiveness of ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukaemia (BFR CLL) as compared to physician's choice. The five-year follow-up of this phase 3 trial showed that ofatumumab therapy resulted in a numerically but ... Read more >>

Br. J. Haematol. (British journal of haematology)
[2020, 189(4):689-693]

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Efficacy and Safety of Duvelisib Following Disease Progression on Ofatumumab in Patients with Relapsed/Refractory CLL or SLL in the DUO Crossover Extension Study.

Matthew S Davids, Bryone J Kuss, Peter Hillmen, Marco Montillo, Carol Moreno, James Essell, Nicole Lamanna, Zsolt Nagy, Constantine S Tam, Stephan Stilgenbauer, Paolo Ghia, Julio Delgado, Stephanie Lustgarten, David T Weaver, Hagop Youssoufian, Ulrich Jäger,

PURPOSE:In the phase III DUO trial, duvelisib, an oral dual PI3K-δ,γ inhibitor, demonstrated significantly improved efficacy versus ofatumumab [median (m) progression-free survival (PFS), 13.3 vs. 9.9 months (HR, 0.52; P < 0.0001); overall response rate [ORR], 74% vs. 45% (P < 0.0001)], with a manageable safety profile in patients with ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2020, 26(9):2096-2103]

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Diagnosis and treatment of autoimmune hemolytic anemia in adults: Recommendations from the First International Consensus Meeting.

Ulrich Jäger, Wilma Barcellini, Catherine M Broome, Morie A Gertz, Anita Hill, Quentin A Hill, Bernd Jilma, David J Kuter, Marc Michel, Marco Montillo, Alexander Röth, Sacha S Zeerleder, Sigbjørn Berentsen,

Autoimmune hemolytic anemias (AIHAs) are rare and heterogeneous disorders characterized by the destruction of red blood cells through warm or cold antibodies. There is currently no licensed treatment for AIHA. Due to the paucity of clinical trials, recommendations on diagnosis and therapy have often been based on expert opinions and ... Read more >>

Blood Rev. (Blood Reviews)
[2020, 41:100648]

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Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial.

Marco Montillo, Árpád Illés, Tadeusz Robak, Alexander S Pristupa, Malgorzata Wach, Miklós Egyed, Julio Delgado, Wojciech Jurczak, Franck Morschhauser, Anna Schuh, Herbert Eradat, Sanatan Shreay, Jacqueline C Barrientos, Andrew D Zelenetz,

BACKGROUND:In a phase 3 randomized, double-blind, placebo-controlled trial, treatment with idelalisib, a phosphoinositol-3 kinase δ inhibitor, + bendamustine/rituximab improved progression-free survival (PFS) and overall survival (OS) in adult patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Here we report the results of health-related quality of life (HRQL) analyses from this ... Read more >>

Health Qual Life Outcomes (Health and quality of life outcomes)
[2019, 17(1):173]

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Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Talha Munir, Jennifer R Brown, Susan O'Brien, Jacqueline C Barrientos, Paul M Barr, Nishitha M Reddy, Steven Coutre, Constantine S Tam, Stephen P Mulligan, Ulrich Jaeger, Thomas J Kipps, Carol Moreno, Marco Montillo, Jan A Burger, John C Byrd, Peter Hillmen, Sandra Dai, Anita Szoke, James P Dean, Jennifer A Woyach,

Ibrutinib, a once-daily oral inhibitor of Bruton's tyrosine kinase, is approved in the United States and Europe for treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The phase 3 RESONATE study showed improved efficacy of single-agent ibrutinib over ofatumumab in patients with relapsed/refractory CLL/SLL, including ... Read more >>

Am. J. Hematol. (American journal of hematology)
[2019, 94(12):1353-1363]

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Duvelisib: a new phosphoinositide-3-kinase inhibitor in chronic lymphocytic leukemia.

Anna M Frustaci, Alessandra Tedeschi, Marina Deodato, Giulia Zamprogna, Roberto Cairoli, Marco Montillo,

P110-γ and -δ act in lymphocytes chemotaxis, presenting distinct, nonredundant roles in B- and T-cell migration and adhesion to stromal cells. Moreover, phosphoinositide-3-kinase-γ inhibition contributes to regulate macrophage polarization inhibiting cancer growth. Duvelisib (IPI-145) is an oral first-in-class, dual phosphoinositide-3-kinase inhibitor targeting p110-δ/γ exerting its activity in preclinical studies across ... Read more >>

Future Oncol (Future Oncology)
[2019, 15(19):2227-2239]

Cited: 1 time

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Olaptesed pegol (NOX-A12) with bendamustine and rituximab: a phase IIa study in patients with relapsed/refractory chronic lymphocytic leukemia.

Michael Steurer, Marco Montillo, Lydia Scarfò, Francesca R Mauro, Johannes Andel, Sophie Wildner, Livio Trentin, Ann Janssens, Sonja Burgstaller, Anna Frömming, Thomas Dümmler, Kai Riecke, Matthias Baumann, Diana Beyer, Stéphanie Vauléon, Paolo Ghia, Robin Foà, Federico Caligaris-Cappio, Marco Gobbi,

Olaptesed pegol (NOX-A12) is a pegylated structured L-oligoribonucleotide that binds and neutralizes CXCL12, a chemokine tightly regulating the life cycle of chronic lymphocytic leukemia cells. The resulting inhibition of CXCR4 and CXCR7 signaling reduces the protective activity of the bone marrow and lymph node microenvironment. CXCL12 inhibition mobilizes chronic lymphocytic ... Read more >>

Haematologica (Haematologica)
[2019, 104(10):2053-2060]

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Ibrutinib for the treatment of chronic lymphocytic leukemia.

Marina Deodato, Anna Maria Frustaci, Giulia Zamprogna, Roberto Cairoli, Marco Montillo, Alessandra Tedeschi,

INTRODUCTION:Chemoimmunotherapy has improved outcomes in chronic lymphocytic leukemia, yet it is not curative, with very high relapse rates, and is associated with a significant risk of toxicities. Moreover, patients with higher-risk genetic abnormalities continue to experience poorer outcomes and lower survival. Recently, novel targeted therapies have been developed to increase ... Read more >>

Expert Rev Hematol (Expert review of hematology)
[2019, 12(5):273-284]

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Long-term follow-up of the RESONATE phase 3 trial of ibrutinib vs ofatumumab.

John C Byrd, Peter Hillmen, Susan O'Brien, Jacqueline C Barrientos, Nishitha M Reddy, Steven Coutre, Constantine S Tam, Stephen P Mulligan, Ulrich Jaeger, Paul M Barr, Richard R Furman, Thomas J Kipps, Patrick Thornton, Carol Moreno, Marco Montillo, John M Pagel, Jan A Burger, Jennifer A Woyach, Sandra Dai, Remus Vezan, Danelle F James, Jennifer R Brown,

Ibrutinib, a once-daily oral inhibitor of Bruton tyrosine kinase, has greatly improved outcomes for patients with chronic lymphocytic leukemia (CLL). The phase 3 RESONATE trial, which compared single-agent ibrutinib to ofatumumab in high-risk, relapsed patients with CLL, provided support for approval of ibrutinib in the United States and Europe. We ... Read more >>

Blood (Blood)
[2019, 133(19):2031-2042]

Cited: 3 times

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The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL.

Ian W Flinn, Peter Hillmen, Marco Montillo, Zsolt Nagy, Árpád Illés, Gabriel Etienne, Julio Delgado, Bryone J Kuss, Constantine S Tam, Zoltán Gasztonyi, Fritz Offner, Scott Lunin, Francesco Bosch, Matthew S Davids, Nicole Lamanna, Ulrich Jaeger, Paolo Ghia, Florence Cymbalista, Craig A Portell, Alan P Skarbnik, Amanda F Cashen, David T Weaver, Virginia M Kelly, Barry Turnbull, Stephan Stilgenbauer,

Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of hematologic malignancies. PI3K-δ,γ signaling can promote B-cell proliferation and survival in clonal B-cell malignancies, such as chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). In a phase 1 study, ... Read more >>

Blood (Blood)
[2018, 132(23):2446-2455]

Cited: 11 times

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Management of adverse events associated with idelalisib treatment in chronic lymphocytic leukemia and follicular lymphoma: A multidisciplinary position paper.

Antonio Cuneo, Giovanni Barosi, Romano Danesi, Stefano Fagiuoli, Paolo Ghia, Alfredo Marzano, Marco Montillo, Venerino Poletti, Pierluigi Viale, Pier Luigi Zinzani,

The introduction of new therapeutic agents in chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL), including the new kinase inhibitor idelalisib, has changed the therapeutic landscape of these diseases. However, the use of idelalisib is associated with a peculiar profile of side effects, which require an optimization of the current ... Read more >>

Hematol Oncol (Hematological oncology)
[2019, 37(1):3-14]

Cited: 2 times

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Prognostic Factors for Complete Response to Ibrutinib in Patients With Chronic Lymphocytic Leukemia: A Pooled Analysis of 2 Clinical Trials.

Susan M O'Brien, Samantha Jaglowski, John C Byrd, Rajat Bannerji, Kristie A Blum, Christopher P Fox, Richard R Furman, Peter Hillmen, Thomas J Kipps, Marco Montillo, Jeff Sharman, Sam Suzuki, Danelle F James, Alvina D Chu, Steven E Coutre,

Importance:Ibrutinib, a first-in-class Bruton tyrosine kinase inhibitor taken once daily, is approved in the United States for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and allows for treatment without chemotherapy. Extended treatment with ibrutinib has demonstrated increased complete response (CR) rates over time. Objective:To analyze baseline factors that predict CR ... Read more >>

JAMA Oncol (JAMA oncology)
[2018, 4(5):712-716]

Cited: 3 times

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Efficacy of bendamustine and rituximab as first salvage treatment in chronic lymphocytic leukemia and indirect comparison with ibrutinib: a GIMEMA, ERIC and UK CLL FORUM study.

Antonio Cuneo, George Follows, Gian Matteo Rigolin, Alfonso Piciocchi, Alessandra Tedeschi, Livio Trentin, Angeles Medina Perez, Marta Coscia, Luca Laurenti, Gerardo Musuraca, Lucia Farina, Alfredo Rivas Delgado, Ester Maria Orlandi, Piero Galieni, Francesca Romana Mauro, Carlo Visco, Angela Amendola, Atto Billio, Roberto Marasca, Annalisa Chiarenza, Vittorio Meneghini, Fiorella Ilariucci, Monia Marchetti, Stefano Molica, Francesca Re, Gianluca Gaidano, Marcos Gonzalez, Francesco Forconi, Stefania Ciolli, Agostino Cortelezzi, Marco Montillo, Lukas Smolej, Anna Schuh, Toby A Eyre, Ben Kennedy, Kris M Bowles, Marco Vignetti, Javier de la Serna, Carol Moreno, Robin Foà, Paolo Ghia, ,

We performed an observational study on the efficacy of ben-damustine and rituximab (BR) as first salvage regimen in chronic lymphocytic leukemia (CLL). In an intention-to-treat analysis including 237 patients, the median progression-free survival (PFS) was 25 months. The presence of del(17p), unmutated IGHV and advanced stage were associated with a ... Read more >>

Haematologica (Haematologica)
[2018, 103(7):1209-1217]

Cited: 4 times

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Practical management of ibrutinib in the real life: Focus on atrial fibrillation and bleeding.

Giuseppe Boriani, Paolo Corradini, Antonio Cuneo, Anna Falanga, Robin Foà, Gianluca Gaidano, Paolo Prospero Ghia, Maurizio Martelli, Roberto Marasca, Massimo Massaia, Francesca Romana Mauro, Giorgio Minotti, Stefano Molica, Marco Montillo, Antonio Pinto, Alessandra Tedeschi, Umberto Vitolo, Pier Luigi Zinzani,

The Bruton tyrosine kinase inhibitor ibrutinib (IB) has attained an important role in the treatment of patients with chronic lymphocytic leukaemia, mantle cell lymphoma, and Waldenström macroglobulinemia, significantly improving clinical outcomes. However, IB therapy has been associated with an increased risk of atrial fibrillation (AF) and bleeding. We report on ... Read more >>

Hematol Oncol (Hematological oncology)
[2018, 36(4):624-632]

Cited: 2 times

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Venetoclax-Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia.

John F Seymour, Thomas J Kipps, Barbara Eichhorst, Peter Hillmen, James D'Rozario, Sarit Assouline, Carolyn Owen, John Gerecitano, Tadeusz Robak, Javier De la Serna, Ulrich Jaeger, Guillaume Cartron, Marco Montillo, Rod Humerickhouse, Elizabeth A Punnoose, Yan Li, Michelle Boyer, Kathryn Humphrey, Mehrdad Mobasher, Arnon P Kater,

BACKGROUND:Venetoclax inhibits BCL2, an antiapoptotic protein that is pathologically overexpressed and that is central to the survival of chronic lymphocytic leukemia cells. We evaluated the efficacy of venetoclax in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. METHODS:In this randomized, open-label, phase 3 trial, we randomly ... Read more >>

N. Engl. J. Med. (The New England journal of medicine)
[2018, 378(12):1107-1120]

Cited: 68 times

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Ibrutinib and its use in the treatment of chronic lymphocytic leukemia.

Anna Maria Frustaci, Alessandra Tedeschi, Marina Deodato, Maddalena Mazzucchelli, Roberto Cairoli, Marco Montillo,

Ibrutinib represents a revolution in chronic lymphocytic leukemia treatment scenario providing results never seen before and offering an effective therapy even in high-risk patients with really poor outcome after chemoimmunotherapy. Thanks to longer updates, on one hand, ibrutinib has confirmed its efficacy continuing to show clinical benefits over time; on ... Read more >>

Future Oncol (Future Oncology)
[2018, 14(8):681-697]

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No improvement in long-term survival over time for chronic lymphocytic leukemia patients in stereotyped subsets #1 and #2 treated with chemo(immuno)therapy.

Panagiotis Baliakas, Mattias Mattsson, Anastasia Hadzidimitriou, Eva Minga, Andreas Agathangelidis, Lesley-Ann Sutton, Lydia Scarfo, Zadie Davis, Xiao-Jie Yan, Karla Plevova, Yorick Sandberg, Fie J Vojdeman, Tatiana Tzenou, Charles C Chu, Silvio Veronese, Larry Mansouri, Karin E Smedby, Véronique Giudicelli, Florence Nguyen-Khac, Panagiotis Panagiotidis, Gunnar Juliusson, Achilles Anagnostopoulos, Marie-Paule Lefranc, Livio Trentin, Mark Catherwood, Marco Montillo, Carsten U Niemann, Anton W Langerak, Sarka Pospisilova, Niki Stavroyianni, Nicholas Chiorazzi, David Oscier, Diane F Jelinek, Tait Shanafelt, Nikos Darzentas, Chrysoula Belessi, Frederic Davi, Paolo Ghia, Richard Rosenquist, Kostas Stamatopoulos,

Haematologica (Haematologica)
[2018, 103(4):e158-e161]

Cited: 2 times

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Chronic Lymphocytic Leukemia with Mutated IGHV4-34 Receptors: Shared and Distinct Immunogenetic Features and Clinical Outcomes.

Aliki Xochelli, Panagiotis Baliakas, Ioannis Kavakiotis, Andreas Agathangelidis, Lesley-Ann Sutton, Eva Minga, Stavroula Ntoufa, Eugen Tausch, Xiao-Jie Yan, Tait Shanafelt, Karla Plevova, Myriam Boudjogra, Davide Rossi, Zadie Davis, Alba Navarro, Yorick Sandberg, Fie Juhl Vojdeman, Lydia Scarfo, Niki Stavroyianni, Andrey Sudarikov, Silvio Veronese, Tatiana Tzenou, Teodora Karan-Djurasevic, Mark Catherwood, Dirk Kienle, Maria Chatzouli, Monica Facco, Jasmin Bahlo, Christiane Pott, Lone Bredo Pedersen, Larry Mansouri, Karin E Smedby, Charles C Chu, Véronique Giudicelli, Marie-Paule Lefranc, Panagiotis Panagiotidis, Gunnar Juliusson, Achilles Anagnostopoulos, Ioannis Vlahavas, Darko Antic, Livio Trentin, Marco Montillo, Carsten Niemann, Hartmut Döhner, Anton W Langerak, Sarka Pospisilova, Michael Hallek, Elias Campo, Nicholas Chiorazzi, Nikos Maglaveras, David Oscier, Gianluca Gaidano, Diane F Jelinek, Stephan Stilgenbauer, Ioanna Chouvarda, Nikos Darzentas, Chrysoula Belessi, Frederic Davi, Anastasia Hadzidimitriou, Richard Rosenquist, Paolo Ghia, Kostas Stamatopoulos,

Purpose: We sought to investigate whether B cell receptor immunoglobulin (BcR IG) stereotypy is associated with particular clinicobiological features among chronic lymphocytic leukemia (CLL) patients expressing mutated BcR IG (M-CLL) encoded by the IGHV4-34 gene, and also ascertain whether these associations could refine prognostication.Experimental Design: In a series of 19,907 ... Read more >>

Clin. Cancer Res. (Clinical cancer research : an official journal of the American Association for Cancer Research)
[2017, 23(17):5292-5301]

Cited: 2 times

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Is HBV prophylaxis required during CLL treatment with ibrutinib?

Alessandra Tedeschi, Anna Maria Frustaci, Maddalena Mazzucchelli, Roberto Cairoli, Marco Montillo,

Leuk. Lymphoma (Leukemia & lymphoma)
[2017, 58(12):2966-2968]

Cited: 3 times

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Impact of ibrutinib dose adherence on therapeutic efficacy in patients with previously treated CLL/SLL.

Paul M Barr, Jennifer R Brown, Peter Hillmen, Susan O'Brien, Jacqueline C Barrientos, Nishitha M Reddy, Steven Coutre, Stephen P Mulligan, Ulrich Jaeger, Richard R Furman, Florence Cymbalista, Marco Montillo, Claire Dearden, Tadeusz Robak, Carol Moreno, John M Pagel, Jan A Burger, Samuel Suzuki, Juthamas Sukbuntherng, George Cole, Danelle F James, John C Byrd,

Ibrutinib, an oral inhibitor of Bruton's tyrosine kinase (BTK), at a once-daily dose of 420 mg achieved BTK active-site occupancy in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) that was maintained at 24 hours. It is unknown if intermittent interruption of ibrutinib therapy contributes to altered clinical outcomes. ... Read more >>

Blood (Blood)
[2017, 129(19):2612-2615]

Cited: 23 times

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Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.

Andrew D Zelenetz, Jacqueline C Barrientos, Jennifer R Brown, Bertrand Coiffier, Julio Delgado, Miklós Egyed, Paolo Ghia, Árpád Illés, Wojciech Jurczak, Paula Marlton, Marco Montillo, Franck Morschhauser, Alexander S Pristupa, Tadeusz Robak, Jeff P Sharman, David Simpson, Lukáš Smolej, Eugen Tausch, Adeboye H Adewoye, Lyndah K Dreiling, Yeonhee Kim, Stephan Stilgenbauer, Peter Hillmen,

Bendamustine plus rituximab is a standard of care for the management of patients with relapsed or refractory chronic lymphocytic leukaemia. New therapies are needed to improve clinically relevant outcomes in these patients. We assessed the efficacy and safety of adding idelalisib, a first-in-class targeted phosphoinositide-3-kinase δ inhibitor, to bendamustine plus ... Read more >>

Lancet Oncol. (The Lancet. Oncology)
[2017, 18(3):297-311]

Cited: 61 times

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Paving the way for new agents; is standard chemotherapy part of the treatment paradigm for chronic lymphocytic leukemia in the future?

Anna Maria Frustaci, Marco Montillo, Paola Picardi, Maddalena Mazzucchelli, Roberto Cairoli, Alessandra Tedeschi,

First and second generation tyrosine kinase inhibitors, represent a new, fully biologic and targeted approach to chronic lymphocytic leukemia and allowed to obtain high responses and acceptable tolerability even in elderly and high risk patients. On the other hand, prolonged experience with these agents has raised some questions on unexpected ... Read more >>

Expert Rev Hematol (Expert review of hematology)
[2016, 9(7):679-693]

Cited: 1 time

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Ofatumumab plus chlorambucil as a first-line therapy in less fit patients with chronic lymphocytic leukemia: analysis of COMPLEMENT1 and other monoclonal antibodies association data.

Anna Maria Frustaci, Alessandra Tedeschi, Paola Picardi, Maddalena Mazzucchelli, Roberto Cairoli, Marco Montillo,

The management of patients with chronic lymphocytic leukemia (CLL) has radically improved over the last few years with the addition of anti-CD20 monoclonal antibodies (MoAbs) to chemotherapy. Chlorambucil has been considered for decades as a suitable therapeutic option for frail patients. Taking into account the advantage offered by the addition ... Read more >>

Ther Adv Hematol (Therapeutic advances in hematology)
[2016, 7(4):222-230]

Cited: 0 times

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