UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042023 |
|---|---|
| Receipt number | R000045524 |
| Scientific Title | A Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia |
| Date of disclosure of the study information | 2020/10/10 |
| Last modified on | 2022/10/11 08:20:58 |
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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
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
nobuhiro.koga@servier.com
Sponsor or person
Institute
Kyowa Kirin Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045524
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