دورية أكاديمية
أعرض في EDS

Clinical Trial Simulation To Optimize Trial Design for Fludarabine Dosing Strategies in Allogeneic Hematopoietic Cell Transplantation.

التفاصيل البيبلوغرافية
العنوان: Clinical Trial Simulation To Optimize Trial Design for Fludarabine Dosing Strategies in Allogeneic Hematopoietic Cell Transplantation.
المؤلفون: Langenhorst JB; Pediatric Blood and Marrow Transplant Program, Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.; Laboratory of Translational Immunology, University Medical Centre Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.; Model-informed drug development consultant, Pharmetheus AB, Uppsala, Sweden., Dorlo TPC; Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital, Netherlands Cancer Institute, Amsterdam, The Netherlands., van Kesteren C; Pediatric Blood and Marrow Transplant Program, Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands., van Maarseveen EM; Department of Clinical Pharmacy, University Medical Centre Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands., Nierkens S; Pediatric Blood and Marrow Transplant Program, Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.; Laboratory of Translational Immunology, University Medical Centre Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands., de Witte MA; Department of Hematology, University Medical Centre Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands., Boelens JJ; Pediatric Blood and Marrow Transplant Program, Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.; Stem Cell Transplant and Cellular Therapies, Pediatrics, Memorial Sloan Kettering Cancer Centre, New York, New York, USA., Huitema ADR; Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek Hospital, Netherlands Cancer Institute, Amsterdam, The Netherlands.; Department of Clinical Pharmacy, University Medical Centre Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.
المصدر: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2020 May; Vol. 9 (5), pp. 272-281. Date of Electronic Publication: 2020 Apr 21.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2163-8306 (Electronic) Linking ISSN: 21638306 NLM ISO Abbreviation: CPT Pharmacometrics Syst Pharmacol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2015- : Hoboken, NJ : Wiley
Original Publication: New York, NY : Nature Pub. Group
مواضيع طبية MeSH: Research Design*, Antineoplastic Agents/*administration & dosage , Hematopoietic Stem Cell Transplantation/*methods , Vidarabine/*analogs & derivatives, Adult ; Combined Modality Therapy ; Computer Simulation ; Hematologic Neoplasms/therapy ; Humans ; Randomized Controlled Trials as Topic/methods ; Vidarabine/administration & dosage
مستخلص: Optimal fludarabine exposure has been associated with improved treatment outcome in allogeneic hematopoietic cell transplantation, suggesting potential benefit of individualized dosing. A randomized controlled trial (RCT) comparing alternative fludarabine dosing strategies to current practice may be warranted, but should be sufficiently powered for a relevant end point, while still feasible to enroll. To find the optimal design, we simulated RCTs comparing current practice (160 mg/m 2 ) to either covariate-based or therapeutic drug monitoring (TDM)-guided dosing with potential outcomes being nonrelapse mortality (NRM), graft failure, or relapse, and ultimately overall survival (covering all three aforementioned outcomes). The inclusion in each treatment arm (n) required to achieve 80% power was calculated for all combinations of end points and dosing comparisons. The trial requiring the lowest n for sufficient power compared TDM-guided dosing to current practice with NRM as primary outcome (n = 70, NRM decreasing from 21% to 5.7%). We conclude that a superiority trial is feasible.
(© 2020 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.)
References: Bone Marrow Transplant. 2011 Jan;46(1):20-6. (PMID: 20383215)
Blood. 2007 Feb 1;109(3):944-50. (PMID: 17032921)
Biol Blood Marrow Transplant. 2017 Oct;23(10):1701-1713. (PMID: 28684371)
J Hematol Oncol. 2013 Feb 08;6:15. (PMID: 23394705)
Bone Marrow Transplant. 2013 Apr;48(4):537-43. (PMID: 23222384)
Curr Opin Hematol. 2014 Nov;21(6):466-9. (PMID: 25159712)
Blood Adv. 2019 Jul 23;3(14):2179-2187. (PMID: 31324638)
Lancet Haematol. 2016 Nov;3(11):e526-e536. (PMID: 27746112)
N Engl J Med. 2010 Nov 25;363(22):2091-101. (PMID: 21105791)
J Clin Oncol. 2013 Jul 1;31(19):2437-49. (PMID: 23715573)
Clin Lymphoma Myeloma Leuk. 2014 Dec;14(6):493-500. (PMID: 25034142)
J Clin Oncol. 2013 Feb 20;31(6):701-9. (PMID: 23129746)
Bone Marrow Transplant. 2014 Mar;49(3):355-60. (PMID: 24270391)
Clin Transplant. 2012 Mar-Apr;26(2):284-91. (PMID: 21919963)
J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Jun 15;1055-1056:81-85. (PMID: 28445850)
Lancet Haematol. 2017 Apr;4(4):e183-e191. (PMID: 28330607)
Lancet Haematol. 2015 May;2(5):e194-203. (PMID: 26688094)
Bone Marrow Transplant. 2015 Dec;50(12):1542-50. (PMID: 26367221)
Transl Res. 2016 Sep;175:103-115.e4. (PMID: 27094990)
Bone Marrow Transplant. 2004 Jul;34(1):29-35. (PMID: 15156161)
Bone Marrow Transplant. 2013 May;48(5):666-70. (PMID: 23085830)
N Engl J Med. 2016 Sep 8;375(10):944-53. (PMID: 27602666)
Biol Blood Marrow Transplant. 2008 Aug;14(8):859-66. (PMID: 18640568)
Bone Marrow Transplant. 2017 Apr;52(4):580-587. (PMID: 27991894)
Int J Hematol. 2013 May;97(5):581-98. (PMID: 23585244)
Clin Pharmacokinet. 2019 May;58(5):627-637. (PMID: 30327943)
Bone Marrow Transplant. 2016 Apr;51(4):492-500. (PMID: 26726943)
معلومات مُعتمدة: P30 CA008748 United States CA NCI NIH HHS
المشرفين على المادة: 0 (Antineoplastic Agents)
FA2DM6879K (Vidarabine)
P2K93U8740 (fludarabine)
تواريخ الأحداث: Date Created: 20200121 Date Completed: 20210811 Latest Revision: 20210811
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC7239337
DOI: 10.1002/psp4.12486
PMID: 31957334
قاعدة البيانات: MEDLINE
الوصف
تدمد:2163-8306
DOI:10.1002/psp4.12486