UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002581 |
|---|---|
| Receipt number | R000003147 |
| Scientific Title | Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) CML-08: A Multi-Center Observational Study for Children with Chronic Phase of Chronic Myeloid Leukemia |
| Date of disclosure of the study information | 2009/10/05 |
| Last modified on | 2019/10/12 10:54:09 |
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Basic information
Public title
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) CML-08: A Multi-Center Observational Study for Children with Chronic Phase of Chronic Myeloid Leukemia
Acronym
A Multi-Center Observational Study for Children with Chronic Phase of CML: JPLSG CML-08
Scientific Title
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) CML-08: A Multi-Center Observational Study for Children with Chronic Phase of Chronic Myeloid Leukemia
Scientific Title:Acronym
A Multi-Center Observational Study for Children with Chronic Phase of CML: JPLSG CML-08
Region
| Japan |
Condition
Condition
Chronic Phase of Chronic Myeloid Leukemia (CML) in children
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For the pediatric patients with chronic phase of CML, we study the efficacy and the safety of the treatment using imatinib as a first-line.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
5-year progression-free survival (5y-PFS)
Key secondary outcomes
5-year event-free survival (5y-EFS)
5-year overall survival (5y-OS)
Cumulative rates of CHR, CCyR, and MMR
Correlation of the prognosis with early BCR-ABL/ABL mRNA ratio
Correlation of the efficacy with bone marrow markers, imatinib trough level, BCR-ABL kinase domain mutaions
Incidence rates of adverse effects
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Newly diagnosed BCR-ABL-positive chronic phase of CML
2) Age <18 years at initial diagnosis
3) Diagnosis after October 1st, 2009
4) Imatinib as first-line treatment
5) Written informed consent
Key exclusion criteria
CML without BCR-ABL rearrangement detectable by PCR
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimada |
Organization
Keio University School of Medicine
Division name
Department of Pediatrics
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633816
hshimada@a5.keio.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Saito |
Organization
Japanese Pediatric Leukemia/Lymphoma study Group
Division name
Data Center
Zip code
460-0001
Address
National Nagoya Hospital, 4-1-1, Sannomaru, Naka-ku, Nagoya
TEL
052-951-1111
Homepage URL
http://jplsg
nsgdata@nnh.hosp.go.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
JPLSG参加181施設
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 05 | 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
22
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
| 2009 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 01 | Day |
Other
Other related information
We conduct a prospective study on the assumption that patients are treated based on the guideline.
Management information
Registered date
| 2009 | Year | 10 | Month | 04 | Day |
Last modified on
| 2019 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003147
