UMIN-CTR Clinical Trial

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
Email	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
Email	all-asp19@pref-hp.miyazaki.miyazaki.jp

Sponsor
Institute	Japan Children's Cancer Study Group(JCCG)
Institute
Department

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
Email	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	Enrolling by invitation
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
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 06 Month 02 Day
Last modified on	2020 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046373

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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