Phase 2 study of nilotinib in pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia-Reference-Cited by-同舟云学术

Phase 2 study of nilotinib in pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia

Published:2019-12-05 Issue:23 Volume:134 Page:2036-2045
ISSN:0006-4971
Container-title:Blood
language:en
Short-container-title:

Author:

Hijiya Nobuko¹^ORCID,Maschan Alexey²^ORCID,Rizzari Carmelo³,Shimada Hiroyuki⁴^ORCID,Dufour Carlo⁵,Goto Hiroaki⁶,Kang Hyoung Jin⁷,Guinipero Terri⁸,Karakas Zeynep⁹,Bautista Francisco¹⁰,Ducassou Stéphane¹¹,Yoo Keon Hee¹²,Zwaan Christian Michel¹³¹⁴¹⁵,Millot Frédéric¹⁶,Aimone Paola¹⁷,Allepuz Alex¹⁷,Quenet Sara¹⁸,Hourcade-Potelleret Florence¹⁹,Hertle Sabine²⁰,Sosothikul Darintr²¹

Affiliation:

1. Department of Pediatrics, Columbia University Medical Center, New York, NY;

2. Dmitrii Rogachev Federal Research Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russia;

3. Department of Pediatrics, Pediatric Hematology Oncology Unit, University of Milano Bicocca, Monza e Brianza per il Bambino e la sua Mamma Foundation, Azienda Socio Sanitaria Territoriale Monza, Monza, Italy;

4. Department of Pediatrics, Keio University School of Medicine, Tokyo, Japan;

5. IRCCS Hematology Unit, Istituto Giannina Gaslini, Genoa, Italy;

6. Division of Hematology/Oncology, Kanagawa Children’s Medical Center, Yokohama, Japan;

7. Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Cancer Research Institute, Seoul National University Children’s Hospital, Seoul, South Korea;

8. Department of Pediatrics, Division of Pediatric Hematology/Oncology/Bone Marrow Transplantation, Nationwide Children’s Hospital, The Ohio State University, Columbus, OH;

9. Department of Pediatrics, Hematology/Oncology Unit, Istanbul University, Istanbul School of Medicine, Istanbul, Turkey;

10. Department of Pediatric Oncology, Hospital Niño Jesus, Madrid, Spain;

11. Centre Hospitalier Universitaire (CHU) Bordeaux, Oncologie Hématologie Pédiatrique, Université de Bordeaux, Unité INSERM U1218, Bordeaux, France;

12. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea;

13. Department of Pediatric Oncology/Hematology, Erasmus Medical Center-Sophia Children’s Hospital, Rotterdam, The Netherlands;

14. Princess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands;

15. Innovative Therapies for Children with Cancer Consortium, Utrecht, The Netherlands;

16. Unité d’Onco-Hématologie Pédiatrique, Clinical Investigation Center 1402 INSERM, CHU de Poitiers, Poitiers, France;

17. Novartis Pharma AG, Basel, Switzerland;

18. Clinical Development and Analytics,

19. Pharmacokinetics Sciences, and

20. Trial Management, Novartis Pharma AG, Basel, Switzerland; and

21. Department of Pediatrics, Hematology and Oncology Division, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

Abstract

Key Points Nilotinib demonstrated efficacy and a manageable safety profile in pediatric patients with newly diagnosed and pretreated Ph+ CML-CP.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

Link

http://ashpublications.org/blood/article-pdf/134/23/2036/1545301/bloodbld2019000069.pdf

Reference37 articles.

1. Chronic myeloid leukemia in children: clinical findings, management, and unanswered questions;Hijiya;Pediatr Clin North Am,2015

2. Treatment of pediatric chronic myeloid leukemia in the year 2010: use of tyrosine kinase inhibitors and stem-cell transplantation;Suttorp;Hematology Am Soc Hematol Educ Program,2010

3. Cancer incidence and survival among children and adolescents;Ries

4. Novartis Pharmaceuticals Corporation . Novartis drug Tasigna (nilotinib) secures EU approval for first and second-line treatment of Ph+ CML-CP in children. https://www.novartis.com/news/media-releases/novartis-drug-tasignar-nilotinib-secures-eu-approval-first-and-second-line-treatment-ph-cml-cp-children. Accessed 20 June 2019.

5. U.S. Food and Drug Administration . FDA approves dasatinib for pediatric patients with CML. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-dasatinib-pediatric-patients-cml. Accessed 20 June 2019.

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