Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Myeloid Leukemia

Conditions

Acute Myeloid Leukemia

Shota Kato, Jun Matsubayashi, Rina Nojima, Hayato Miyachi, Hiromichi Matsushita et al. (21 authors)

Blood2025-11-03

10.1182/blood-2025-3512

Fusion partner–specific mutation profiles and KRAS mutations as adverse prognostic factors in MLL-rearranged AML

H. Matsuo, Kenichi Yoshida, Kana Nakatani, Yutarou Harata, Moe Higashitani et al. (24 authors)

Blood Advances2020-09-2925 citations

10.1182/bloodadvances.2020002457

Recurrent Genomic Aberrations of D-Type Cyclins Are Therapeutic Targets of CDK4/6 Inhibitors in t(8;21) and MLL-Rearranged Acute Myeloid Leukemia

H. Matsuo, Kenichi Yoshida, Kazutaka Fukumura, Kana Nakatani, Yuki Noguchi et al. (27 authors)

Blood2018-11-29

10.1182/blood-2018-99-111073

Distinct Clinical and Cytogenetic Characteristics and Poor Prognosis in Children with Acute Erythroid Leukemia: A Report from the JPLSG AML-05 Study

Daisuke Tomizawa, Akio Tawa, Nobutaka Kiyokawa, Akitoshi Kinoshita, Hayato Miyachi et al. (16 authors)

Blood2015-12-03

10.1182/blood.v126.23.4945.4945

Double CEBPA Mutations Are Not Associated With Favorable Clinical Outcome In Pediatric AML: A Report From The Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)

H. Matsuo, Mio Kajihara, Daisuke Tomizawa, Tomoyuki Watanabe, Akiko Saito et al. (15 authors)

Blood2013-11-15

10.1182/blood.v122.21.4942.4942

Poor Prognosis With Different Induction Rate Was Observed In Children With Acute Myeloid Leukemia and FLT3-ITD According To The ITD/WT Allelic Ratio: A Result From The Japanese Pediatric Leukemia/Lymphoma Study Group

Akira Shimada, Yuka Yamashita, Daisuke Tomizawa, Akio Tawa, Tomoyuki Watanabe et al. (23 authors)

Blood2013-11-15

10.1182/blood.v122.21.3891.3891

Interventions

Two common courses of remission induction multi-agent combination chemotherapy for all the eligible patients. For Low Risk group (LR), 3 courses of intensification multi-agent combination chemotherap

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) AML (excluding AML with Down syndrome, APL, secondary AML, NK/myeloid leukemia, and granulocytic sarcoma) 2) age less than 18 years old 3) ECOG performance status score of 0-3 4) no history of previous chemotherapy or radiation therapy 5) sufficient hepatic, renal, and cardiac function satisfying the laboratory data listed below; T-Bil: within 3x of the age-dependent normal range ALT: within 10x of the institutional normal range serum creatinine value: within 3x of the age-dependent normal range ECG:no severe abnormalities (example; QTc>0.45sec) 6)written informed consent obtained from guardians

Exclusion criteria

Exclusion criteria: 1)CNS hemorrhage which is likely to interfere protocol therapy 2)uncontrolled DM 3)severe mental abnormalities 4)pregnancy 5)unmanageable infectious disease 6)history of congenital or acquired immunodeficiency 7)any inappropriate status judged by physician

Design outcomes

Primary

Measure	Time frame
Three-year event-free survival rate of the each risk group	—

Secondary

Measure	Time frame
For the each risk group, 3-year EFS; rate of adverse events defined by Common Terminology Criteria for Adverse Events(CTCAE) ver3.0; compliance rate of protocol specified regimen. Overall, 3-year EFS and OS; induction remission rate; remission rate after initial course of induction chemotherapy; compliance rate of protocol specified regimen.	—

Countries

Japan

Contacts

Public ContactAkio Tawa

National Hospital Organization Osaka National Hospital Department of Pediatrics

tawa@onh.go.jp06-6942-1331

Outcome results

None listed