UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001125 |
|---|---|
| Receipt number | 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 21:11:45 |
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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
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
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001373
