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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002581
Receipt No. 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 2019/04/11

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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
Middle name
Last name Hiroyuki Shimada
Organization Keio University School of Medicine
Division name Department of Pediatrics
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email hshimada@a5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Saito
Organization Japanese Pediatric Leukemia/Lymphoma study Group
Division name Data Center
Zip code
Address National Nagoya Hospital, 4-1-1, Sannomaru, Naka-ku, Nagoya
TEL 052-951-1111
Homepage URL http://jplsg
Email nsgdata@nnh.hosp.go.jp

Sponsor
Institute Japanese Pediatric Leukemia/Lymphoma Study Group
Institute
Department

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
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 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
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 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003147

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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