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). (9th July 2022)

• Record Type: Journal Article
• Authors: Tomizawa, Daisuke; Tsujimoto, Shin-ichi; Tanaka, Shiro; Matsubayashi, Jun; Aoki, Takahiro; Iwamoto, Shotaro; Hasegawa, Daisuke; Nagai, Kozo; Nakashima, Kentaro; Kawaguchi, Koji; Deguchi, Takao; Kiyokawa, Nobutaka; Ohki, Kentaro; Hiramatsu, Hidefumi; Shiba, Norio; Terui, Kiminori; Saito, Akiko Moriya; Kato, Motohiro; Taga, Takashi; Koshinaga, Tsugumichi; Adachi, Souichi
• Is Part Of: Japanese journal of clinical oncology. Volume 52:Number 10(2022)
• Page Start: 1225
• Page End: 1231
• Publication Date: 2022-07-09
• Subjects: acute myeloid leukemia -- gemtuzumab ozogamicin -- minimal residual disease -- children -- randomized trial; Oncology -- Periodicals; Cancer -- Periodicals; 616.994005
• DOI: 10.1093/jjco/hyac105
• Languages: English
• ISSNs: 0368-2811

Abstract

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). Abstract : JPLSG-AML-20 is a Japanese nationwide multicenter phase III study for children with AML evaluating MRD-based risk stratification and the safety and efficacy of gemtuzumab ozogamicin-combined post-induction chemotherapy for non-low-risk patients.