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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001125
Receipt No. R000001373
Scientific Title Imatinib pharmacokinetics and its correlation with response in chronic-phase chronic myelogenous leukemia
Date of disclosure of the study information 2008/05/01
Last modified on 2016/10/02

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Basic information
Public title Imatinib pharmacokinetics and its correlation with response in chronic-phase chronic myelogenous leukemia
Acronym Imatinib pahrmacokinetics and response in CML
Scientific Title Imatinib pharmacokinetics and its correlation with response in chronic-phase chronic myelogenous leukemia
Scientific Title:Acronym Imatinib pahrmacokinetics and response in CML
Region
Japan

Condition
Condition chronic myelogenous leukemia in chronic-phase
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Correlate trough levels of imatinib with cytogenetic and molecular response.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes molecular response
Key secondary outcomes cytogenetic response

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 Chronic myelogenous leukemia in 1st chronic-phase
Pts on imatinib more than 1 year
Pts on a regular maintenance dose at least 8 months during initial 1st year of imatinib therapy
Key exclusion criteria Previous history of anti-leukemic therapy other than imatinib (except hydroxycarbamide at initial phase or steroids for non-anti-leukemia purposes)
Pts taking drugs with known pahrmacokinetic interaction with imatinib
Cr equal to or greater than 1.6mg/dl, AST/ALT equal to or greater than 2 times of NUL
Positive serologic tests for syphilis, HBV or HCV
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoki Ueda
Organization Keio University School of Medicine
Division name Novartis Pharma Program for Clinical Therapeutics of Hematologic Malignancy
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoki Ueda
Organization Keio University School of Medicine
Division name Novartis Pharma Program for Clinical Therapeutics of Hematologic Malignancy
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Novartis Pharma
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2008 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2008 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information cross-sectional study
correlate trough levels of imatinib with cytogenetic and molecular response

Management information
Registered date
2008 Year 04 Month 22 Day
Last modified on
2016 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001373

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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