Evaluation of high-dose cytarabine in induction therapy for children with de novo acute myeloid leukemia: a study protocol of the Japan Children's Cancer Group Multi-Center Seamless Phase II–III Randomized Trial (JPLSG AML-12). (28th April 2018)

• Record Type: Journal Article
• Authors: Tomizawa, Daisuke; Tanaka, Shiro; Hasegawa, Daisuke; Iwamoto, Shotaro; Hiramatsu, Hidefumi; Kiyokawa, Nobutaka; Miyachi, Hayato; Horibe, Keizo; Saito, Akiko Moriya; Taga, Takashi; Adachi, Souichi
• Is Part Of: Japanese journal of clinical oncology. Volume 48:Number 6(2018)
• Page Start: 587
• Page End: 593
• Publication Date: 2018-04-28
• Subjects: acute myeloid leukemia -- high-dose cytarabine -- minimal residual disease -- children -- randomized trial; Oncology -- Periodicals; Cancer -- Periodicals; 616.994005
• DOI: 10.1093/jjco/hyy061
• Languages: English
• ISSNs: 0368-2811

Abstract

Abstract : We are conducting a multi-center trial in Japan, which is a seamless Phase II–III study in previously untreated, newly diagnosed patients with acute myeloid leukemia at <18 years of age. Abstract: The purpose of this study is to compare the efficacy and safety of combination therapy (HD-ECM) including high-dose cytarabine in initial induction therapy with that of combination therapy (ECM) involving the continuous administration of cytarabine for previously untreated, newly diagnosed patients with AML at <18 years of age. This is a seamless Phase II–III clinical trial, consisting of Phase II and III parts. In the Phase II part, the safety of the experimental treatment (HD-ECM) will be examined. Subsequently, the Phase III study will compare the efficacy and safety of HD-ECM with that of standard ECM. The primary endpoint of the Phase II study is the early mortality rate. The primary endpoints of the Phase III study are the 3-year event-free survival rate and the positive minimal residual disease rate by flow cytometry after initial induction therapy. This trial has been registered at the UMIN Clinical Trials Registry (UMIN000013288).