UMIN-CTR Clinical Trial

Basic information
Public title	A Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Acronym	A Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Scientific Title	A Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Scientific Title:Acronym	A Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Region	Japan

Condition
Condition	Acute Lymphoblastic Leukemia
Classification by specialty	Hematology and clinical oncology Pediatrics
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The objectives of the study are to 1) assess the safety and tolerability of a single dose of Pegaspargase in Japanese patients (dose confirmation) in the tolerability assessment period; and 2) to assess the safety, pharmacokinetics and efficacy of Pegaspargase in the treatment of newly diagnosed untreated acute lymphoblastic leukemia in Japanese patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Efficacy Percentage of patients who have a plasma asparaginase activity of more than 0.1 IU / mL 14 days(336 hours) after the first dose of Pegaspargase . Time Frame: 14 days after the first dose of Pegaspargase in Remission Induction phase
Key secondary outcomes	Safety Incidence and nature of treatment-emergent adverse events (TEAEs) and drug-related TEAEs. Efficacy Plasma Asparaginase Activity with therapeutic threshold of 0.1 IU/mL Asparaginase measured by coupled enzymatic activity assay. Survival rate at 1 year after the start of study treatment . Event-free survival rate at 1 year after the start of study treatment .

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pegaspargase
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	21 years-old >=
Gender	Male and Female
Key inclusion criteria	Age 1 to 21 years at the time of informed consent. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. Newly diagnosed, untreated precursor B-cell ALL. No prior therapy for malignant tumor such as chemotherapy and radiation therapy before signing the informed consent. Life expectancy of at least 6 months from the date of enrollment.
Key exclusion criteria	Mature B-cell ALL ; Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL. Preexisting known coagulopathy. History of pancreatitis. Continuous use of corticosteroids. Prior treatment or possible prior treatment with an L-asparaginase preparation. History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs. Pregnant
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Nobuhiro Middle name Last name Koga
Organization	Nihon Servier Company Limited
Division name	Clinical Operation Department International Center for Therapeutic Research - Japan
Zip code	113-0033
Address	5F Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, tokyo, Japan
TEL	03-5842-7119
Email	nobuhiro.koga@servier.com

Public contact
Name of contact person	1st name Nobuhiro Middle name Last name Koga
Organization	Nihon Servier Company Limited
Division name	Clinical Operation Department International Center for Therapeutic Research - Japan
Zip code	113-0033
Address	5F Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, tokyo, Japan
TEL	03-5842-7119
Homepage URL
Email	nobuhiro.koga@servier.com

Sponsor
Institute	Kyowa Kirin Co., Ltd.
Institute
Department

Funding Source
Organization	INSTITUT DE RECHERCHES INTERNATIONALES SERVIER (I.R.I.S.)
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization Review Board for Clinical Trials Nagoya.
Address	4-1-1 Sannomaru, Naka-ku Nagoya, Aichi 460-0001, Japan
Tel	052-951-1111
Email	311-chiken@mail.hosp.go.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	独立行政法人国立病院機構名古屋医療センター（愛知県） 埼玉県立小児医療センター（埼玉県） 学校法人聖路加国際大学 聖路加国際病院（東京都） 国立研究開発法人国立がん研究センター中央病院（東京都） 鹿児島大学病院（鹿児島県） 社会医療法人 北楡会 札幌北楡病院（北海道） 兵庫県立こども病院（兵庫県） 東京都立小児総合医療センター（東京都） 地方独立行政法人 神奈川病院機構　神奈川県立こども医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 10 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	28
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	2019 Year 03 Month 15 Day
Date of IRB	2019 Year 06 Month 23 Day
Anticipated trial start date	2019 Year 10 Month 18 Day
Last follow-up date	2023 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 06 Day
Last modified on	2022 Year 10 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045524