UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002026 |
|---|---|
| Receipt number | R000002466 |
| Scientific Title | Clinical study for the first relapsed ALL in children. JPLSG ALL-R08-I: Prospective observational study |
| Date of disclosure of the study information | 2009/06/01 |
| Last modified on | 2017/01/31 12:42:12 |
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Basic information
Public title
Clinical study for the first relapsed ALL in children. JPLSG ALL-R08-I: Prospective observational study
Acronym
Prospective observational study for the relapsed ALL in children: JPLSG ALL-R08-I
Scientific Title
Clinical study for the first relapsed ALL in children. JPLSG ALL-R08-I: Prospective observational study
Scientific Title:Acronym
Prospective observational study for the relapsed ALL in children: JPLSG ALL-R08-I
Region
| Japan |
Condition
Condition
first relapsed acute lymphoblastic leukemia 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 first relapsed ALL, we study the treatment and the prognosis.
We study the practical treatment and the prognosis in Japanese pediatric patients with first relapsed ALL.
Basic objectives2
Others
Basic objectives -Others
observation
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
3 year-event free survival rate(3y-EFS), 3 year-overall survival rate(3y-OS)
Key secondary outcomes
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
| 0 | years-old | <= |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. first relapsed ALL
2. Be<18 year old at initial diagnosis and be <20 year old at the enrollment
3. Parents(or leagal guardians) must provide signed, written informed consent.
Key exclusion criteria
Patients with mature B-ALL, Ph chromosome positive ALL or MLL gene rearrangement positive ALL.
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chitose Ogawa |
Organization
National Cancer Center Hospital
Division name
Department of Pediatric Oncology
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
chitoseo@qb3.so-net.ne.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(2751)
Homepage URL
http://jplsg
nsgdata@nnh.hosp.go.jp
Sponsor or person
Institute
Japanese Peditric Leukemia/Lymphoma Study Group
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
| 2009 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 01 | Day |
Other
Other related information
1. 3y-EFS and 3y-OS in total, each risk group and post-transplant relapsed group
remission induction rate in each group
2. 3y-EFS and 3y-OS in S1
3. 3y-EFS, 3y-OS, adverse events and the used drugs with nelaribine
4. Second progression free survival
5. Remission induction rates in each type of treatment regimen
6. Second relapse rate by the treatrent regimen in isolated extramedullary relapse
7. incidence rates of adverse effects
8. Adverse events and prognosis in the transplantation type
Management information
Registered date
| 2009 | Year | 06 | Month | 01 | Day |
Last modified on
| 2017 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002466
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
