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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000989
Receipt No. R000001191
Scientific Title 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
Date of disclosure of the study information 2008/01/22
Last modified on 2019/01/30

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Basic information
Public title 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
Acronym AML-D05
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Taga
Organization Shiga University of Medical Science
Division name Department of Pediatrics
Zip code
Address Seta-tsukinowa, Otsu, Shiga
TEL 077-548-2228
Email ttaga@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Taga
Organization Shiga University of Medical Science
Division name Departiment of Pediatrics
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2007 Year 11 Month 29 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000001191

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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