UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019878 |
|---|---|
| Receipt number | R000022964 |
| Scientific Title | Prospective observational study of relapsed and refractory pediatric acute lymphoblastic leukemia |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2021/05/25 09:29:13 |
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Basic information
Public title
Prospective observational study of relapsed and refractory pediatric acute lymphoblastic leukemia
Acronym
Prospective observational study of relapse and refractory pediatric ALL
Scientific Title
Prospective observational study of relapsed and refractory pediatric acute lymphoblastic leukemia
Scientific Title:Acronym
Prospective observational study of relapse and refractory pediatric ALL
Region
| Japan |
Condition
Condition
acute lymphoblastic leukemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To accumulate clinical information prospectively of pediatric patients with relapsed or refractory acute lymphoblastic leukemia.
To collect leukemia samples from patients with relapsed or refractory acute lymphoblastic leukemia for use of various basic/translational studies.
Basic objectives2
Others
Basic objectives -Others
Prospective observational study and sample collection.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
2 year EFS in all cases, in subgroups according to risk classification in 1st relapse cases, or numbers of relapse.
Odd ratio in reinduction rate between clofarabine regimens and other regimens.
Correlation between results (IC50 values) of in vitro drug sensitivity tests and reinduction rate.
Key secondary outcomes
2 year OS in all cases, or in subgroups according to risk classification in 1st relapse cases or numbers of relapse.
2nd progression free survival rate.
Reinduction rate.
Odds ratio in EFS between clofarabine regimens and other regimens.
Odds ratio in OS between clofarabine regimens and other regimens.
OS according to regimens or drugs used in reinduction therapy.
Correlation between results (IC50 values) of in vitro drug sensitivity tests and reinduction rate in patients treated by clofarabine.
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
| Not applicable |
Age-upper limit
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.relapsed or refractory ALL
2.Age<18y at diagnosis and <25y at relapse.
3.Patients who have been registered in the JPLSG CHM-14 study.
4.Informed consent is necessary.
5.Not included in other JPLSG studies.
Key exclusion criteria
None
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Goto |
Organization
Kanagawa Children's Medical Center
Division name
Division of Hematology/Oncology
Zip code
2328555
Address
2-138-4 Mutsukawa Minami-ku, Yokohama
TEL
045-711-2351
hgotou@kcmc.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Goto |
Organization
Kanagawa Children's Medical Center
Division name
Division of Hematology/Oncology
Zip code
2328555
Address
2-138-4 Mutsukawa Minami-ku, Yokohama
TEL
0457112351
Homepage URL
hgotou@kcmc.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group
Institute
Department
Personal name
Funding Source
Organization
Study for establishment of standard therapies in pediatric hematological cancers (lymphoid tumors)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Sanofi KK
IRB Contact (For public release)
Organization
Ethics Committee, Kanagawa Children's Medical Center
Address
2-138-4 Mutsukawa Minami-Ku, Yokohama
Tel
045-711-2351
kisaka@kcmc.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | 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
76
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
| 2015 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design; prospective observational study.
Subjects; Patients with relapse/refractory ALL , treated in institutions participating JPLSG
Objective; To observe prognosis of patients treated according to each institutional decisions. To analyze the effect of clofarabine in reinduction regimens.
data collection; disease information, reinduction regimen, results of reinduction
Basic research; biobanking of relapse/refractory ALL samples. In vitro drug sensitivity test using ALL samples.
Management information
Registered date
| 2015 | Year | 11 | Month | 20 | Day |
Last modified on
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022964
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
