UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000352 |
|---|---|
| Receipt number | R000000451 |
| Scientific Title | Evaluation of safety and tolerability of the initial treatment with imatinib for chronic myeloid leukemia in chronic phase (Tokyo STI Study Group) |
| Date of disclosure of the study information | 2006/03/10 |
| Last modified on | 2007/09/13 12:28:20 |
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Basic information
Public title
Evaluation of safety and tolerability of the initial treatment with imatinib for chronic myeloid leukemia in chronic phase (Tokyo STI Study Group)
Acronym
Evaluation of safety and tolerability of imatinib for CML-CP (TSSG study)
Scientific Title
Evaluation of safety and tolerability of the initial treatment with imatinib for chronic myeloid leukemia in chronic phase (Tokyo STI Study Group)
Scientific Title:Acronym
Evaluation of safety and tolerability of imatinib for CML-CP (TSSG study)
Region
| Japan |
Condition
Condition
Chronic myelogenous leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to evaluate the safety and tolerability of the initial treatment with imatinib for Philadelphia positive chronic myeloid leukemia in chronic phase.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Optimal imatinib dosage based on the grading of adverse event at 6th months
Key secondary outcomes
Hematological/cytogenetical response by imatinib dosage at 6 months
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
Orally administer imatinib 400mg/day
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Philadelphia positive chronic myeloid leukemia in chronic phase.
2) Age over 15
3) Written informed consent to participate the trial
Key exclusion criteria
1) Pregnant and/or lactating woman
2) WBC<3000/mm3
3) serum bilirubin or creatinine level above twice as the upper limit of normal
4) GPT or GOT level above 3 times as the upper limit of normal
5) PS >=3
6) In accelerate or blastic phase
7) Ph positivity <30 % by IFN-a treatment
8) Past history of BMT or PBSCT
9) Receiving investigational agents within 4 weeks
10) Grade 3 heart failure
11) Receiving another anti-leukemic therapy including IFN-a
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okamoto |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kanda |
Organization
University of Tokyo Hospital
Division name
Department of Hematology & Oncology
Zip code
Address
TEL
Homepage URL
ycanda-tky@umin.ac.jp
Sponsor or person
Institute
Tokyo STI Study Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2006 | Year | 03 | 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
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
| 2002 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 03 | Month | 08 | Day |
Last modified on
| 2007 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000451
