UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000989 |
|---|---|
| Receipt number | 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 09:47:14 |
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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
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/
ttaga@belle.shiga-med.ac.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group(JPLSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001191
