UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040630 |
|---|---|
| Receipt number | R000046373 |
| Scientific Title | Pharmacokinetics of asparaginase in patients with acute lymphoblastic leukemia: prospective observational study. |
| Date of disclosure of the study information | 2020/06/02 |
| Last modified on | 2023/06/05 13:03:30 |
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Basic information
Public title
Pharmacokinetics of asparaginase in patients with acute lymphoblastic leukemia: prospective observational study.
Acronym
JCCG ALL-ASP19
Scientific Title
Pharmacokinetics of asparaginase in patients with acute lymphoblastic leukemia: prospective observational study.
Scientific Title:Acronym
JCCG ALL-ASP19
Region
| Japan |
Condition
Condition
acute lymphoblastic leukemia (ALL)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify silent inactivation of asparaginase by measuring serum asparaginase activity.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of silent inactivation of asparaginase in patients with ALL.
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
| Not applicable |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Newly diagnosed acute lymphoblastic leukemia
2) Registered to JPLSG CHM-14 study
3) Age below 40 years old
4) informed consent from patients or guardians
Key exclusion criteria
Judged to be inappropriate for registration by investigators
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | hidemi |
| Middle name | |
| Last name | SHIMONODAN |
Organization
Miyazaki Prefectual Miyazaki Hospital
Division name
Division of Pediatrics
Zip code
880-8510
Address
5-30,kitatakamatu, Miyazaki, Miyazaki 880-8510, JAPAN
TEL
0985-24-4181
shimono@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | hidemi |
| Middle name | |
| Last name | SHIMONODAN |
Organization
Miyazaki Prefectual Miyazaki Hospital
Division name
Division of Pediatrics
Zip code
880-8510
Address
5-30,kitatakamatu, Miyazaki, Miyazaki 880-8510, JAPAN
TEL
0985-24-4181
Homepage URL
all-asp19@pref-hp.miyazaki.miyazaki.jp
Sponsor or person
Institute
Japan Children's Cancer Study Group(JCCG)
Institute
Department
Personal name
Funding Source
Organization
Gold Ribbon Network
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyazaki Prefectual Miyazaki Hospital
Address
5-30,kitatakamatu, Miyazaki, Miyazaki 880-8510, JAPAN
Tel
0985-24-4181
ikeno-takuya@pref.miyazaki.lg.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
| 2020 | Year | 06 | Month | 02 | 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
| 2020 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046373
