UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-D05: Phase II Study of Risk Stratified Multi-drug Chemotherapy on Down Syndrome with Newly diagnosed Childhood Acute Myeloid Leukemia
Title of the study (Brief title)	AML-D05
Region	Japan

Condition
Condition	Acute myeloid Leukemia Myelodysplastic syndrome
Classification by specialty	Hematology and clinical oncology Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate an efficacy and safety of treatment strategy according to the risk stratification based on response to the initial induction therapy on Down syndrome more than 4 months and less than 18 years old with newly diagnosed childhood acute myeloid leukemia(AML) and myelodysplastic syndrome(MDS) excluding acute promyelocytic leukemia(APL). For the Standard Risk group (SR), to evaluate efficacy and safety of the multi-agent combination chemotherapy reducing etoposide compared to AML 99 Down study. For the High Risk group (HR), to evaluate efficacy and safety of the multi-agent combination chemotherapy consisted of continuous and high-dose cytarabine
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Two-year event-free survival rate
Key secondary outcomes	Remission rate after initial induction chemotherapy Remission rate for high risk group Three-year overall survival rate Two-year event free survival for each risk group Three-year overall survival for each risk group Incidence of FLT3-ITD Two-year event free survival with or without FLT3-ITD Incidence of adverse events during chemotherapy Compliance rate of protocol specified regimen Three-year event free survival of the patients less than 4 years old

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Single common courses of remission induction multi-agent combination chemotherapy for all the eligible patients For Standard Risk group(SR), 4 courses of intensification multi-agent combination chemotherapy For High Risk group(HR), 2 courses of remission induction multi-agent combination chemotherapy followed by 4 courses of intensification multi-agent combination chemotherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	4 months-old <=
Age-upper limit	216 months-old >
Gender	Male and Female
Key inclusion criteria	1)AML(excluding APL) and MDS with Down syndrome 2)age more than 4 month and less than 18 years old 3)ECOG performance status score of 0-3 4)no history of previous chemotherapy (except administration of cytarabine for transient myeloproliferative disorder) or radiotherapy 5)sufficient hepatic, renal, and cardiac function satisfying the laboratory data listed below: T-Bil: within 3 times of the age-dependent normal range serum creatinine value: within 3 times of the age-dependent normal range ECG: no severe abnormalities (example; QTc >0.45) 6)written informed consent obtained from guardians
Key exclusion criteria	1)CNS hemorrhage which is likely to intervent protocol therapy 2)uncontrolled DM 3)uncontrolled cardiac failure 4)pregnancy 5)unmanageable infectious disease 6)history of congenital or acquired immunodeficiency 7)CNS leukemia 8)any inappropriate status judged by physician
Target sample size	73

Research contact person
Name of lead principal investigator	Takashi Taga
Organization	Shiga University of Medical Science
Division name	Department of Pediatrics
Address	Seta-tsukinowa, Otsu, Shiga
TEL	077-548-2228
Email	ttaga@belle.shiga-med.ac.jp

Public contact
Name of contact person	Takashi Taga
Organization	Shiga University of Medical Science
Division name	Departiment of Pediatrics
Address	Seta-tsukinowa, Otsu, Shiga, 520-2192
TEL	077-548-2228
Homepage URL	http://www.jplsg.jp/
Email	ttaga@belle.shiga-med.ac.jp

Sponsor
Institute	Japanese Pediatric Leukemia/Lymphoma Study Group(JPLSG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2008 Year 01 Month 22 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2007 Year 11 Month 29 Day
Anticipated trial start date	2008 Year 01 Month 01 Day
Last follow-up date	2013 Year 12 Month 31 Day
Date of closure to data entry	2014 Year 03 Month 31 Day
Date trial data considered complete	2014 Year 06 Month 30 Day
Date analysis concluded	2014 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2008 Year 01 Month 22 Day
Last modified on	2019 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001191