UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035692
Receipt No. 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 2019/03/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 CCyR was achieved with prior TKI treatment, but later showed resistance.
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
Middle name
Last name Naoto Takahashi
Organization Akita University Graduate School of Medicine
Division name Department of Hematology, Nephrology, and Rheumatology
Zip code
Address 1-1-1 Hondo, Akita, Akita
TEL 018-884-6116
Email naotot@doc.med.akita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Clinical Research, Innovation and Education Center, Tohoku University Hospital
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
Email k15kenkyu@crieto.hosp.tohoku.ac.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Institute
Department

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
Tel
Email

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)
大阪市立大学医学部附属病院(大阪府)
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)
Osaka City University Hospital (Osaka)
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 Open public recruiting
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
2021 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 01 Month 28 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040620

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.