NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000511

Registered date:01/11/2006

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAcute Myeloid Leukemia
Date of first enrollment2006/11/01
Target sample size254
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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 chemotherapy. For Intermediate Risk group (IR), 3 courses of intensification multi-agent combination chemotherapy. For High Risk group (HR), 1 to 3 courses of intensification multi-agent combination chemotherapy followed by allogeneic hematopoietic stem cell transplantation.

Outcome(s)

Primary OutcomeThree-year event-free survival rate of the each risk group
Secondary OutcomeFor 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.

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum18years-old
GenderMale and Female
Include criteria1) 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
Exclude criteria1)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

Related Information

Contact

public contact
Name Akio Tawa
Address 2-1-14Hoenzaka, Chuo-ku, Osaka city Japan
Telephone 06-6942-1331
E-mail tawa@onh.go.jp
Affiliation National Hospital Organization Osaka National Hospital Department of Pediatrics
scientific contact
Name Akio Tawa
Address 2-1-14Hoenzaka, Chuo-ku, Osaka city Japan
Telephone 06-6942-1331
E-mail tawa@onh.go.jp
Affiliation National Hospital Organization Osaka National Hospital Department of Pediatrics