A phase III clinical trial evaluating efficacy and safety of minimal residual disease-based risk stratification for children with acute myeloid leukemia, incorporating a randomized study of gemtuzumab ozogamicin in combination with post-induction chemotherapy for non-low-risk patients (JPLSG-AML-20).

Abstract

The purpose of this study is to establish a treatment with appropriate intensity for children (<16 years old at diagnosis) with de novo acute myeloid leukemia (excluding acute promyelocytic leukemia and myeloid leukemia associated with Down syndrome) according to a risk stratification based on recurrent leukemic cytogenetic abnormalities and flow-cytometric minimal residual disease at end of initial induction chemotherapy and to validate the safety and efficacy of gemtuzumab ozogamicin (GO)-combined post-induction chemotherapy for the non-low-risk (non-LR) patients. The primary endpoint of this phase III study is three-year disease-free survival rate, which will be compared between the GO and non-GO arms of the non-LR (intermediate-risk and high-risk [HR]) patients. All HR patients will be allocated to allogeneic hematopoietic stem cell transplantation in first remission. This trial has been registered at the Japan Registry of Clinical Trials (jRCTs041210015).

• Authors: Daisuke Tomizawa, Shin-Ichi Tsujimoto, Shiro Tanaka, Jun Matsubayashi, Takahiro Aoki, Shotaro Iwamoto, Daisuke Hasegawa, Kozo Nagai, Kentaro Nakashima, Koji Kawaguchi, Takao Deguchi, Nobutaka Kiyokawa, Kentaro Ohki, Hidefumi Hiramatsu, Norio Shiba, Kiminori Terui, Akiko Moriya Saito, Motohiro Kato, Takashi Taga, Tsugumichi Koshinaga, Souichi Adachi
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 52 Issue 10 Pg. 1225-1231 (Oct 06 2022) ISSN: 1465-3621 [Electronic] England
• PMID: 35809896 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: © The Author(s) 2022. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [email protected].

Chemical References

• Aminoglycosides
• Antibodies, Monoclonal, Humanized
• Gemtuzumab

Topics

• Adolescent
• Aminoglycosides (adverse effects)
• Antibodies, Monoclonal, Humanized (adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Child
• Gemtuzumab
• Humans
• Induction Chemotherapy
• Leukemia, Myeloid, Acute
• Neoplasm, Residual (drug therapy)
• Risk Assessment