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Paediatric Strategy Forum for medicinal product development for acute myeloid leukaemia in children and adolescents: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson ADJ, Zwaan CM, Kolb EA, Karres D, Guillot J, Kim SY, Marshall L, Tasian SK, Smith M, Cooper T, Adamson PC, Barry E, Benettaib B, Binlich F, Borgman A, Brivio E, Capdeville R, Delgado D, Faller D, Fogelstrand L, Fraenkel PG, Hasle H, Heenen D, Kaspers G, Kieran M, Klusmann JH, Lesa G, Ligas F, Mappa S, Mohamed H, Moore A, Morris J, Nottage K, Reinhardt D, Scobie N, Simko S, Winkler T, Norga K, Reaman G, Vassal G. Pearson ADJ, et al. Among authors: faller d. Eur J Cancer. 2020 Sep;136:116-129. doi: 10.1016/j.ejca.2020.04.038. Epub 2020 Jul 17. Eur J Cancer. 2020. PMID: 32688206 Free PMC article.
Asia-inclusive global development of pevonedistat: Clinical pharmacology and translational research enabling a phase 3 multiregional clinical trial.
Zhou X, Friedlander S, Kupperman E, Sedarati F, Kuroda S, Hua Z, Yuan Y, Yamamoto Y, Faller DV, Haikawa K, Nakai K, Bowen S, Dai Y, Venkatakrishnan K. Zhou X, et al. Clin Transl Sci. 2021 May;14(3):1069-1081. doi: 10.1111/cts.12972. Epub 2021 Feb 2. Clin Transl Sci. 2021. PMID: 33503305 Free PMC article. Clinical Trial.
Randomized phase 2 trial of pevonedistat plus azacitidine versus azacitidine for higher-risk MDS/CMML or low-blast AML.
Sekeres MA, Watts J, Radinoff A, Sangerman MA, Cerrano M, Lopez PF, Zeidner JF, Campelo MD, Graux C, Liesveld J, Selleslag D, Tzvetkov N, Fram RJ, Zhao D, Bell J, Friedlander S, Faller DV, Adès L. Sekeres MA, et al. Among authors: faller dv. Leukemia. 2021 Jul;35(7):2119-2124. doi: 10.1038/s41375-021-01125-4. Epub 2021 Jan 22. Leukemia. 2021. PMID: 33483617 Free PMC article. Clinical Trial. No abstract available.
A pragmatic patient-reported outcome strategy for rare disease clinical trials: application of the EORTC item library to myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia.
Bell JA, Galaznik A, Pompilus F, Strzok S, Bejar R, Scipione F, Fram RJ, Faller DV, Cano S, Marquis P. Bell JA, et al. J Patient Rep Outcomes. 2019 Jun 19;3(1):35. doi: 10.1186/s41687-019-0123-4. J Patient Rep Outcomes. 2019. PMID: 31218454 Free PMC article.
305 results