TY - JOUR
T1 - Phase II/III study in children and adolescents with newly diagnosed B-cell precursor acute lymphoblastic leukemia
T2 - Protocol for a nationwide multicenter trial in Japan
AU - Koh, Katsuyoshi
AU - Kato, Motohiro
AU - Saito, Akiko M.
AU - Kada, Akiko
AU - Kawasaki, Hirohide
AU - Okamoto, Yasuhiro
AU - Imamura, Toshihiko
AU - Horibe, Keizo
AU - Manabe, Atsushi
N1 - Publisher Copyright:
© The Author(s) 2018. Published by Oxford University Press. All rights reserved.
PY - 2018/7/1
Y1 - 2018/7/1
N2 - B-cell precursor acute lymphoblastic leukemia is the most common pediatric malignancy, but its treatment needs to be modified to cause low acute toxicity and few late complications with a high cure rate. In this trial, we will stratify patients with B-cell precursor acute lymphoblastic leukemia into standard, intermediate and high risk groups according to prognostic factors. In addition, we will establish an evaluation system for minimal residual disease that will enable us to stratify patients based on minimal residual disease in subsequent clinical trials. We will clarify the impact of dexamethasone/vincristine pulse therapy during maintenance therapy in the standard risk group, and intensive L-asparaginase therapy in the intermediate risk group. In the high risk group, usefulness of vincristine intensification will be assessed. This trial has been registered in the UMIN Clinical.
AB - B-cell precursor acute lymphoblastic leukemia is the most common pediatric malignancy, but its treatment needs to be modified to cause low acute toxicity and few late complications with a high cure rate. In this trial, we will stratify patients with B-cell precursor acute lymphoblastic leukemia into standard, intermediate and high risk groups according to prognostic factors. In addition, we will establish an evaluation system for minimal residual disease that will enable us to stratify patients based on minimal residual disease in subsequent clinical trials. We will clarify the impact of dexamethasone/vincristine pulse therapy during maintenance therapy in the standard risk group, and intensive L-asparaginase therapy in the intermediate risk group. In the high risk group, usefulness of vincristine intensification will be assessed. This trial has been registered in the UMIN Clinical.
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U2 - 10.1093/jjco/hyy071
DO - 10.1093/jjco/hyy071
M3 - Article
C2 - 29860341
AN - SCOPUS:85050435206
SN - 0368-2811
VL - 48
SP - 684
EP - 691
JO - Japanese journal of clinical oncology
JF - Japanese journal of clinical oncology
IS - 7
ER -