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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000352
Receipt No. 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

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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
Email

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
Email ycanda-tky@umin.ac.jp

Sponsor
Institute Tokyo STI Study Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000451

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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