UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035692 |
|---|---|
| Receipt number | R000040620 |
| Scientific Title | Research on the blood concentration of ponatinib and treatment outcome in patients with chronic phase chronic myelogenous leukemia (CP-CML) |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2024/02/07 14:07:56 |
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Basic information
Public title
Research on the blood concentration of ponatinib and treatment outcome in patients with chronic phase chronic myelogenous leukemia (CP-CML)
Acronym
Research on the blood concentration of ponatinib and treatment outcome in patients with chronic phase chronic myelogenous leukemia (CP-CML)
Scientific Title
Research on the blood concentration of ponatinib and treatment outcome in patients with chronic phase chronic myelogenous leukemia (CP-CML)
Scientific Title:Acronym
Research on the blood concentration of ponatinib and treatment outcome in patients with chronic phase chronic myelogenous leukemia (CP-CML)
Region
| Japan |
Condition
Condition
chronic phase chronic myelogenous leukemia (CP-CML)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To examine the relevance between the blood concentration of ponatinib and its therapeutic effects in patients with CP-CML in Japan
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Blood concentration of ponatinib for 48 wks in MMR achievement group
2)Blood concentration of ponatinib for 48 wks in MMR non-achievement group
Key secondary outcomes
1)Blood concentration of ponatinib in group achieving MR4.0 by each time point of 12, 24, 36, and 48 wks
2)Blood concentration of ponatinib in group not achieving MR4.0 by each time point of 12, 24, 36, and 48 wks
3)Blood concentration of ponatinib in group achieving MR4.5 by each time point of 12, 24, 36, and 48 wks
4)blood concentration of ponatinib in group not achieving MR4.5 by each time point of 12, 24, 36, and 48 wks
5)Blood concentration of ponatinib for adverse drug reactions occurred at an incidence of 20% or higher
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as CP-CML using standard hematopathological and cytogenetic criteria.
2) Patients with CP-CML resistant or intolerant to previous medication such as;
1 resistant for prior TKI treatment.
2 CCyR was achieved but not reached MMR, and became intolerance within 12 months after the start of prior TKI treatment.
3) Planned to be treated with ponatinib in clinical practice
4) Aged >= 20 years at informed consent
5) Pancreatic functions are within the following range
1 Lipase <= 106 U/L (2xULN)
2 Amylase <= 264 U/L (2xULN)
6) Written consent is obtained
7) Can visit the study site on specified visit schedule
Key exclusion criteria
1) Have received ponatinib
2) Have an uncontrollable or active heart disease, or history of cardiovascular disease within 2 years such as the following but not limited to:
a. Myocardial infarction (MI)
b. Unstable angina pectoris
c. Congestive heart failure (CHF)
d. Atrial arrhythmia
e. Ventricular arrhythmia
f. Cerebrovascular disorder or transient ischemic attack (TIA)
g. Peripheral arterial occlusive disease requiring vascular regeneration
h. Venous thromboembolism including deep venous thrombosis and pulmonary embolism
3) Have hepatic dysfunction which meet the following 3 criteria simultaneously at the screening point:
a. ALT(GPT) >= 126 U/L (male) / 69 U/L (female), or AST(GOT) >= 90 U/L
b. T-Bil > 3.0 mg/dl
c. ALP < 644 U/L
4) Have a history of pancreatitis within a year prior to screening
5) Have a history of alcoholic abuse
6) Have hypertriglyceridemia (fasting triglyceride level > 450 mg/dl)
7) Have hypertension which is untreated or uncontrollable with antihypertensive agents
8) Have uncontrollable diabetes
9) ABI (ankle-brachial index) <= 0.9 at the screening point
10) Women who are pregnant, might be pregnant or are breastfeeding
11) Men who plan to have a child
12) Determined to be inappropriate for the conduct of this research by attending physician
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Takahashi |
Organization
Akita University Graduate School of Medicine
Division name
Department of Hematology, Nephrology, and Rheumatology
Zip code
010-8543
Address
1-1-1 Hondo, Akita, Akita
TEL
018-884-6116
naotot@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Tohoku University Hospital |
| Middle name | |
| Last name | Clinical Research, Innovation and Education Center, |
Organization
Clinical Research Innovation and Education Center Tohoku University Hospital
Division name
Department of Development Promotion
Zip code
-
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7136
Homepage URL
k15kenkyu@crieto.hosp.tohoku.ac.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
-
Address
1-1-1 Hondo, Akita, Akita
Tel
018-884-6028
soken@hos.akita-u.ac.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
秋田大学医学部附属病院（秋田県）
東北大学病院（宮城県）
山形大学医学部附属病院（山形県）
成田赤十字病院（千葉県）
東京慈恵会医科大学附属柏病院（千葉県）
札幌北楡病院（北海道）
福島県立医科大学附属病院（福島県）
群馬県済生会前橋病院（群馬県）
埼玉医科大学総合医療センター（埼玉県）
順天堂大学医学部附属順天堂医院（東京都）
千葉大学医学部附属病院（千葉県）
兵庫医科大学病院（兵庫県）
Akita University Hospital (Akita)
Tohoku University Hospital (Miyagi)
Yamagata University Hospital (Yamagata)
Japanese Red Cross Narita Hospital (Chiba)
The Jikei University Kashiwa Hospital (Chiba)
Sapporo Hokuyu Hospital (Hokkaido)
Fukushima Medical University Hospital (Fukushima)
Gunma Saiseikai Maebashi Hospital (Gunma)
Saitama Medical Center (Saitama)
Juntendo University Hospital (Tokyo)
Chiba University Hospital (Chiba)
Hyogo College of Medicine College Hospital (Hyogo)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | 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
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
| 2018 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 01 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040620
| 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 |
