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Journal Articles

Avapritinib achieves deep and durable symptom control with a well-tolerated safety profile in ism: Long-term outcomes from pioneer

Free
Tsewang Tashi, Hanneke Oude Elberink, Cem Akin, Mariana Castells, Jens Panse, Deepti Radia, Frank Siebenhaar, Cristina Bulai Livideanu, Karin Hartmann, Sigurd Broesby-Olsen, Tracy George, Vito Sabato, Paul van Daele, Sonia Cerquozzi, Ingunn Dybedal, Joseph Jurcic, Stéphane Barete, Andreas Reiter, Thanai Pongdee, Ruchi Desai, Philippe Schafhausen, Celalettin Ustun, Prithviraj Bose, Peter Vadas, Massimo Triggiani, Patrizia Bonadonna, Daniel Deangelo, Lindsay Rein, Pankit Vachhani, Ilda Bidollari, Hui-Min Lin, Janet Hong, Benjamin Lampson, Ashley Doyle, Ivan Alvarez-Twose, Jason Gotlib
Journal: Blood
Blood (2025) 146 (Supplement 1): 2024.
https://doi.org/10.1182/blood-2025-2024
Published: 2025
Journal Articles

Changes in long-term bone health in patients receiving avapritinib for the treatment of indolent systemic mastocytosis in the pioneer study

Free
Mariana Castells, Vishnu Sundaresh, Jason Gotlib, Tsewang Tashi, Vito Sabato, Cristina Bulai Livideanu, Cem Akin, Deepti Radia, Frank Siebenhaar, Daniel Deangelo, Tracy George, Hui-Min Lin, Janet Hong, Ashley Doyle, Guang Yang, Rachel Erlich, Kate Newberry, Benjamin Lampson, Ivan Alvarez-Twose
Journal: Blood
Blood (2025) 146 (Supplement 1): 5582.
https://doi.org/10.1182/blood-2025-5582
Published: 2025
Journal Articles

Diagnostic evolution in systemic mastocytosis: Clinical impact of who 2022 criteria on smoldering systemic mastocytosis identification in pioneer

Free
Tracy George, Mariana Castells, Cem Akin, Hanneke Oude Elberink, Karin Hartmann, Sigurd Broesby-Olsen, Frank Siebenhaar, Hui-Min Lin, Janet Hong, Benjamin Lampson, Jason Gotlib
Journal: Blood
Blood (2025) 146 (Supplement 1): 5578.
https://doi.org/10.1182/blood-2025-5578
Published: 2025
Journal Articles

An analysis of clonal dynamics in patients with indolent systemic mastocytosis treated with avapritinib in the pioneer study

Free
Jens Panse, Tsewang Tashi, Jason Gotlib, Mariana Castells, Ivan Alvarez-Twose, Cem Akin, Cristina Bulai Livideanu, Vito Sabato, Juliana Schwaab, Andreas Reiter, Sigurd Broesby-Olsen, Frank Siebenhaar, Hui-Min Lin, Janet Hong, Benjamin Lampson, Guang Yang, Tracy George, Deepti Radia
Journal: Blood
Blood (2025) 146 (Supplement 1): 5573.
https://doi.org/10.1182/blood-2025-5573
Published: 2025
Journal Articles

Interpreting tryptase levels and avoiding common pitfalls in screening for clonal mast cell disease

Free
Mariana Castells, Matthew Giannetti, Cem Akin, Joseph Jurcic, Aaron Zakharyan, Ray Coghlan, Karin Hartmann, Vito Sabato
Journal: Blood
Blood (2025) 146 (Supplement 1): 4774.
https://doi.org/10.1182/blood-2025-4774
Published: 2025
Journal Articles

Efficacy and safety results from the primary analysis of the pivotal summit trial: Bezuclastinib in adults with non-advanced systemic mastocytosis

Free
Lindsay Rein, Nathan Boggs, Prithviraj Bose, Brian Modena, Vito Sabato, Karin Hartmann, Cem Akin, Tracy George, Cecilia Arana Yi, Hanneke Oude Elberink, Deepti Radia, Andreas Reiter, Miguel Piris-Villaespesa, Ingunn Dybedal, Jens Panse, Stephen Oh, Pankit Vachhani, Anthony Hunter, Mariana Castells, Cristina Bulai Livideanu, Paul van Daele, Arnold Kirshenbaum, Ivan Alvarez-Twose, Jennifer Vaughn, Minakshi Taparia, Sonia Cerquozzi, Andrzej Mital, Marek Hus, ALESSANDRA ROMANO, John Fahrenholz, Frederick Lansigan, Cristina Papayannidis, Helena Pomares, Michela Rondoni, Celalettin Ustun, Richard Herrscher, Michael Manning, Stéphane Barete, Mar Guilarte, Candido Rivera, Jonathan Bernstein, Peter Vadas, Chiara Elena, Derek McCulloch, Nina Orfali, Clodagh Keohane, Francesco Mannelli, Philippe Schafhausen, Amanda Pilla, Jenna Zhang, Lei Sun, Nisha Shah, Hina Jolin, Rachael Easton, Jessica Sachs, Frank Siebenhaar, Daniel Deangelo
Journal: Blood
Blood (2025) 146 (Supplement 1): 80.
https://doi.org/10.1182/blood-2025-80
Published: 2025
Journal Articles

Updated Efficacy and Safety Results of Patients Receiving Selected 100mg Bezuclastinib Dose and Participating in the Open-Label Extension of Summit: A Randomized, Double-Blind, Placebo Controlled Phase 2 Clinical Trial of Bezuclastinib in Adult Patients with Nonadvanced Systemic Mastocytosis

Free
Lindsay A.M. Rein, Daniel J. DeAngelo, Brian Modena, Stephen Oh, Bulai Livideanu Cridtina, Celalettin Ustun, Nathan Boggs, Michael Manning, Anthony M. Hunter, Cem Akin, Arnold Kirshenbaum, Ingunn Dybedal, Cecilia Y. Arana Yi, Richard Herrscher, Mariana Castells, Frederick Lansigan, Tracy I. George, Jay Patel, Lei Sun, Nisha Shah, Jenna Zhang, Amanda Pilla, Priya Singh, Marcus Carden, Frank Siebenhaar, Prithviraj Bose
Journal: Blood
Blood (2024) 144 (Supplement 1): 4556.
https://doi.org/10.1182/blood-2024-194551
Published: 2024
Journal Articles

Initial Results from Summit: An Ongoing, 3-Part, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of Bezuclastinib in Adult Patients with Nonadvanced Systemic Mastocytosis (NonAdvSM)

Free
Prithviraj Bose, Stephen T. Oh, Brian Modena, Anthony M. Hunter, Cem Akin, Mariana Castells, Michael Manning, Richard Herrscher, Frank Siebenhaar, Daniel J. DeAngelo, Tracy I. George, Benjamin Exter, Jenna Zhang, Amanda Pilla, Hina Jolin, Rachael Easton, Lindsay A.M Rein
Journal: Blood
Blood (2023) 142 (Supplement 1): 77.
https://doi.org/10.1182/blood-2023-178927
Published: 2023
Journal Articles

Summit: A 3-Part, Phase 2 Study of Bezuclastinib (CGT9486), an Oral, Selective, and Potent KIT D816V Inhibitor, in Adult Patients with Nonadvanced Systemic Mastocytosis (NonAdvSM)

Free
Cem Akin, Frank Siebenhaar, Michael W. Deininger, Daniel J. DeAngelo, Tracy I. George, Mariana Castells, Matthew Giannetti, Jason Gotlib, Jessica Sachs, Amanda Pilla, Hina A. Jolin, Prithviraj Bose
Journal: Blood
Blood (2022) 140 (Supplement 1): 6838–6839.
https://doi.org/10.1182/blood-2022-156326
Published: 2022
Journal Articles

Pioneer Part 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib in Indolent Systemic Mastocytosis

Free
Cem Akin, MDPhD, Hanneke Oude Elberink, MD PhD, Jason Gotlib, MD MS, Vito Sabato, MD PhD, Karin Hartmann, MD, Sigurd Broesby-Olsen, MD, Mariana Castells, MD PhD, Tsewang Tashi, MD, Mark L Heaney, MD, Tracy I. George, MD, Frank Siebenhaar, MD, Deepti H. Radia, MRCPI, FRCPath, Massimo Triggiani, MD PhD, Paul van Daele, MD, Daniel J. DeAngelo, MD PhD, Iván Alvarez-Twose, MD PhD, Andreas Reiter, MD, Peter Vadas, MD PhD, Patrizia Bonadonna, MD, Paggy Hew, MS, Hui-Min Lin, PhD, Maria Roche, MS, Marcus Maurer, MD
Journal: Blood
Blood (2020) 136 (Supplement 1): 41–42.
https://doi.org/10.1182/blood-2020-136632
Published: 2020
Journal Articles

Increased Detection of KIT D816V Mutation in Peripheral Blood Samples from Patients with Indolent Systemic Mastocytosis (ISM) in the Phase 2 Pioneer Study Using a High Sensitivity Droplet Digital (dd) PCR Assay Compared with Next Generation Sequencing (NGS)

Free
Tracy I. George, MD, Gerard Hoehn, PhD, Hui-Min Lin, PhD, Stephen Miller, PhD, Cem Akin, MDPhD
Journal: Blood
Blood (2020) 136 (Supplement 1): 7–8.
https://doi.org/10.1182/blood-2020-136930
Published: 2020
Journal Articles

Pioneer: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Avapritinib in Patients with Indolent or Smoldering Systemic Mastocytosis with Symptoms Inadequately Controlled with Standard Therapy

Free
Cem Akin, MD PhD, Vito Sabato, Jason Gotlib, MD MS, Mariana Castells, Michael W. Deininger, Hanneke Oude Elberink, Mark L Heaney, Paul van Daele, Deepti Radia, Massimo Triggiani, Daniel J. DeAngelo, MD, Iván Alvarez-Twose, Sigurd Broesby-Olsen, Tracy I. George, MD, Karin Hartmann, Siebenhaar Frank, Andreas Reiter, Peter Vadas, Patrizia Bonadonna, Jens P. Panse, Petra Staubach-Renz, Knut Brockow, Diamant Thaci, Hui-Min Lin, Andrew Morrison, Brenton Mar, Marcus Maurer
Journal: Blood
Blood (2019) 134 (Supplement_1): 2950.
https://doi.org/10.1182/blood-2019-126035
Published: 2019
Journal Articles

Mastocytosis: 2016 updated WHO classification and novel emerging treatment concepts

Free
Clinical Trials & Observations
Peter Valent, Cem Akin, Dean D. Metcalfe
Journal: Blood
Blood (2017) 129 (11): 1420–1427.
https://doi.org/10.1182/blood-2016-09-731893
Published: 2017
Includes: Supplemental data
Journal Articles

Cladribine for mastocytosis: benefits and risks

Free
Cem Akin
Journal: Blood
Blood (2015) 126 (8): 931–932.
https://doi.org/10.1182/blood-2015-06-649525
Published: 2015
Journal Articles

Midostaurin (PKC412) Demonstrates a High Rate of Durable Responses in Patients with Advanced Systemic Mastocytosis: Results from the Fully Accrued Global Phase 2 CPKC412D2201 Trial

Free
Jason Gotlib, MD MS, Hanneke C. Kluin-Nelemans, MD PhD, Tracy I. George, MD, Cem Akin, MD PhD, Karl Sotlar, MD, Olivier Hermine, MD PhD, Farrukh Awan, MD MS, Elizabeth O Hexner, MD, Michael Mauro, MD, David Sternberg, MD PhD, Matthieu Villeneuve, Fabienne Emery-Salbert, MSc, Eric Stanek, PharmD, Karin Hartmann, MD, Hans-Peter Horny, MD, Peter Valent, MD, Andreas Reiter, MD
Journal: Blood
Blood (2014) 124 (21): 636.
https://doi.org/10.1182/blood.V124.21.636.636
Published: 2014
Journal Articles

Allogeneic Hematopoietic Cell Transplantation Is Effective In Patients With Advanced Systemic Mastocytosis: A Multicenter Retrospective Analysis

Free
Celalettin Ustun, Andreas Reiter, Bart L Scott, MD, Ryotaro Nakamura, Damaj Gandhi, Sebastian Kreil, Ryan Shanley, William J Hogan, MD, Miguel-Angel Perales, MD, Tsiporah B. Shore, Herrad Baurmann, Robert K Stuart, Bernd Gruhn, Michael Doubek, Jack W Hsu, Eleni Tholouli, Tanja Gromke, Lucy A Godley, Livio Pagano, MD, Andrew Gilman, Eva Maria Wagner, MD, Tor Shwayder, Martin Bornhaeuser, Esperanza B Papadopoulos, M.D., Alexandra Boehm, Gregory M Vercellotti, Maria Theresa Van Lint, Christoph Schmid, Werner Rabitsch, MD, Vinod Pullarkat, MD, A. John Barrett, MD, Olivier Hermine, MD, PhD, Hans Gustaf Hagglund, Wolfgang R Sperr, M.D., Uday R Popat, MD, Steven M. Devine, MD, H. Joachim Deeg, MD, Daniel J. Weisdorf, MD, Cem Akin, Peter Valent
Journal: Blood
Blood (2013) 122 (21): 2145.
https://doi.org/10.1182/blood.V122.21.2145.2145
Published: 2013
Journal Articles

Durable Responses and Improved Quality Of Life With Midostaurin (PKC412) In Advanced Systemic Mastocytosis (SM): Updated Stage 1 Results Of The Global D2201 Trial

Free
Jason Gotlib, MD, Hanneke C. Kluin-Nelemans, MD, PhD, Tracy I. George, MD, Cem Akin, MD, PhD, Karl Sotlar, MD, Olivier Hermine, Farrukh Awan, MD, MS, Elizabeth Hexner, MD, Michael Mauro, MD, Rodica Morariu, MD, Margaret Squier, MD, PhD, Matthieu Villeneuve, Fabienne Emery-Salbert, MSc, John Coombs, PharmD, MBA, Karin Hartmann, MD, Hans-Peter Horny, MD, Peter Valent, MD, Andreas Reiter, MD
Journal: Blood
Blood (2013) 122 (21): 106.
https://doi.org/10.1182/blood.V122.21.106.106
Published: 2013
Journal Articles

International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) & European Competence Network on Mastocytosis (ECNM) consensus response criteria in advanced systemic mastocytosis

Free
Jason Gotlib, Animesh Pardanani, Cem Akin, Andreas Reiter, Tracy George, Olivier Hermine, Hanneke Kluin-Nelemans, Karin Hartmann, Wolfgang R. Sperr, Knut Brockow, Lawrence B. Schwartz, Alberto Orfao, Daniel J. DeAngelo, Michel Arock, Karl Sotlar, Hans-Peter Horny, Dean D. Metcalfe, Luis Escribano, Srdan Verstovsek, Ayalew Tefferi, Peter Valent
Journal: Blood
Blood (2013) 121 (13): 2393–2401.
https://doi.org/10.1182/blood-2012-09-458521
Published: 2013
Includes: Supplemental data
Journal Articles

KIT Inhibitor Midostaurin in Patients with Advanced Systemic Mastocytosis: Results of a Planned Interim Analysis of the Global CPKC412D2201 Trial

Free
Jason Gotlib, MD, MS, Hanneke C. Kluin-Nelemans, MD, PhD, Tracy I. George, MD, Cem Akin, MD, PhD, Karl Sotlar, MD, Olivier Hermine, MD, PhD, Farrukh Awan, MD, MS, Elizabeth Hexner, MD, Michael J. Mauro, MD, Rodica Morariu, MD, Margaret Squier, MD, PhD, Matthieu Villeneuve, Fabienne Emery-Salbert, MSc, Karin Hartmann, MD, Hans-Peter Horny, MD, Peter Valent, MD, Andreas Reiter, MD
Journal: Blood
Blood (2012) 120 (21): 799.
https://doi.org/10.1182/blood.V120.21.799.799
Published: 2012
Journal Articles

How I treat patients with advanced systemic mastocytosis

Free
Peter Valent, Wolfgang R. Sperr, Cem Akin
Journal: Blood
Blood (2010) 116 (26): 5812–5817.
https://doi.org/10.1182/blood-2010-08-292144
Published: 2010