Hasserjian, Robert P
Mayo Clinic
Department of Pathology, Massachusetts General Hospital, Boston, MA.
Citations 2
Reducing clinical trial eligibility barriers for patients with MDS: an icMDS position statement
Borate, Uma , Pugh, Kelly , Waller, Allyson, Welkie, Rina Li , Huang, Ying , Stahl, Maximilian , Platzbecker, Uwe , Wei, Andrew H. , Buckstein, Rena , Hasserjian, Robert P. , Fenaux, Pierre , Sallman, David A. , Nimer, Stephen D. , Little, Richard F. , Garcia‐Manero, Guillermo , Odenike, Olatoyosi, Kim, Tae Kon , Greenberg, Peter L. , Xu, Mina L. , Patnaik, Mrinal M. , Padron, Eric , Gore, Steven D. , Churpek, Jane E. , Bennett, John M., Brunner, Andrew M. , Zeidan, Amer M., Zeidan, Amer M. , Platzbecker, Uwe , Sekeres, Mikkael A , Wei, Andrew H , Roboz, Gail J , Loghavi, Sanam , Hasserjian, Robert P , Sallman, David A , Hourigan, Christopher S , Della Porta, Matteo Giovanni , Little, Richard F , Santini, Valeria , Taylor, Justin , Kim, Tae Kon , Halene, Stephanie , Komrokji, Rami S , Griffiths, Elizabeth A. , Greenberg, Peter L , Xie, Zhuoer , Sanz, Guillermo F , Patnaik, Mrinal , Carraway, Hetty E. , Boultwood, Jacqueline , Daver, Naval , Zeidan, Amer M , Churpek, Jane E , Bewersdorf, Jan Philipp , Dezern, Amy Elizabeth , Sekeres, Mikkael A. , Roboz, Gail J. , Savona, Michael R. , Loghavi, Sanam , Hourigan, Christopher S. , Santini, Valeria , Efficace, Fabio , Odenike, Olatoyosi , Komrokji, Rami S. , Xie, Zhuoer , Bejar, Rafael , Sanz, Guillermo , Figueroa, María E. , Abdel‐Wahab, Omar , Starczynowski, Daniel T. , Boultwood, Jacqueline , Daver, Naval , Majeti, Ravindra , List, Alan F. , Brunner, Andrew M., Churpek, Jane
Blood | March 27, 2025 | Volume: 145 | Issue: 13 | Pages: 1369-1381
Abstract Excessively restrictive inclusion and exclusion criteria in clinical trials are one of many barriers to clinical trial enrollment for patients with myelodysplastic syndromes/neoplasms (MDSs). Many organizations are developing efforts to increase clinical trial eligibility; yet, several recent publications focused on patients with MDS suggest that many patients with this disease may be excluded from clinical trials unnecessarily. Clinical trial eligibility should reflect the phase of the study and risks of the agent being studied. Phase 3 trials should be less restrictive than early-phase trials to represent the real-world population as closely as possible. We hypothesize that many clinical trials, particularly phase 3 trials, have unnecessarily restrictive eligibility criteria. This study aims to evaluate the most common eligibility criteria according to phase of trial and to determine whether criteria correspond with drug safety signals. We identified MDS clinical trials registered on ClinicalTrials.gov from 1 January 2000 to 1 September 2023 and analyzed the eligibility criteria of 191 therapeutic MDS trials. We found that categorical inclusion and exclusion criteria are remarkably similar in representation across trial phases. Additionally, only 13% of trials are concordant with drug safety signals, suggesting that the eligibility criteria are often arbitrary. On behalf of the icMDS (International Consortium for Myelodysplastic Syndromes), an association of international MDS experts, we provide a position statement on restrictive eligibility criteria for MDS clinical trials that should be avoided with the aim of removing barriers to clinical trial enrollment.
International Consensus Classification of Myeloid Neoplasms and Acute Leukemias: integrating morphologic, clinical, and genomic data
Arber, Daniel A. , Hasserjian, Robert P. , Borowitz, Michael J., Kvasnicka, Hans Michael , Wang, Sa A. , Bagg, Adam , Barbui, Tiziano , Branford, Susan , Bueso‐Ramos, Carlos E. , Cortes, Jörge E. , Cin, Paola Dal , Dombret, Hervé , Duncavage, Eric J., Ebert, Benjamin L. , Estey, Elihu H. , Foucar, Kathryn , Gangat, Naseema , Gökbuget, Nicola , Hellström‐Lindberg, Eva , Beau, Michelle M. Le , Löwenberg, Bob , Malcovati, Luca , Odenike, Olatoyosi , Papaemmanuil, Elli , Porkka, Kimmo , Radich, Jerald P. , Reiter, Andreas , Rudelius, Martina , Schiffer, Charles A. , Sierra, Jorge , Stone, Richard M. , Tallman, Martin S. , Thiele, Jürgen, Tzankov, Alexandar , Wei, Andrew H. , Weinberg, Olga K. , Wierzbowska, Agnieszka , Cazzola, Mario , Tefferi, Ayalew , Hasserjian, Robert P , Kvasnicka, Hans-Michael , Barbui, Tiziano , Branford, Susan , Cortes, Jorge , DiNardo, Courtney , Ebert, Benjamin L , Gangat, Naseema , Gianelli, Umberto , Hobbs, Gabriela S , Larson, Richard A , Löwenberg, Bob , Macintyre, Elizabeth , Malcovati, Luca , Mullighan, Charles G , Niemeyer, Charlotte Marie , Ogawa, Seishi , Passamonti, Francesco , Porkka, Kimmo , Savona, Michael R , Schmitt-Graeff, Annette , Shimamura, Akiko , Vannucchi, Alessandro M , Vyas, Paresh , Wei, Andrew H , Wierzbowska, Agnieszka , Cazzola, Mario , Döhner, Hartmut , Tzankov, Alexandar , Arber, Daniel A , Orazi, Attilio , Calvo, Katherine R. , DiNardo, Courtney D. , Facchetti, Fabio , Gianelli, Umberto , Godley, Lucy A. , Gotlib, Jason , Hobbs, Gabriela , Hoffman, Ronald , Jabbour, Elias , Kiladjian, Jean‐Jacques , Larson, Richard A. , Loh, Mignon L. , Macintyre, Elizabeth , Mullighan, Charles G. , Órfão, Alberto , Passamonti, Francesco , Pui, Ching-Hon , Rozman, Marı́a , Savona, Michael R. , Stock, Wendy , Tien, Hwei‐Fang , Vannucchi, Alessandro M.
Blood | June 29, 2022 | Volume: 140 | Issue: 11 | Pages: 1200-1228
Abstract The classification of myeloid neoplasms and acute leukemias was last updated in 2016 within a collaboration between the World Health Organization (WHO), the Society for Hematopathology, and the European Association for Haematopathology. This collaboration was primarily based on input from a clinical advisory committees (CACs) composed of pathologists, hematologists, oncologists, geneticists, and bioinformaticians from around the world. The recent advances in our understanding of the biology of hematologic malignancies, the experience with the use of the 2016 WHO classification in clinical practice, and the results of clinical trials have indicated the need for further revising and updating the classification. As a continuation of this CAC-based process, the authors, a group with expertise in the clinical, pathologic, and genetic aspects of these disorders, developed the International Consensus Classification (ICC) of myeloid neoplasms and acute leukemias. Using a multiparameter approach, the main objective of the consensus process was the definition of real disease entities, including the introduction of new entities and refined criteria for existing diagnostic categories, based on accumulated data. The ICC is aimed at facilitating diagnosis and prognostication of these neoplasms, improving treatment of affected patients, and allowing the design of innovative clinical trials.