Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan
NCT ID: NCT01464411
Last Updated: 2011-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 20 years old over
* ECOG performance status (PS) score 0-2
* Adequate organ function (hepatic, renal and lung)
* Signed written informed consent
Exclusion Criteria
* Women who are pregnant or breastfeeding
* The case of Pleural effusion clearly
* Patients with complications or a history of severe or uncontrolled cardiovascular failure following
* have a Myocardial infarction whithin 6 months
* have an Angina within 3 months
* have a Congestive heart failure within 3 months
* have a QTc interval of more than 450msec at baseline
* A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
20 Months
ALL
No
Sponsors
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Kanto CML Study Group
OTHER
Responsible Party
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Takashi Kumagai
M.D, Ph.D
Locations
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Kanto CML Study Group
Tokyo, , Japan
Countries
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Central Contacts
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Facility Contacts
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References
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Iriyama N, Fujisawa S, Yoshida C, Wakita H, Chiba S, Okamoto S, Kawakami K, Takezako N, Kumagai T, Inokuchi K, Ohyashiki K, Taguchi J, Yano S, Igarashi T, Kouzai Y, Morita S, Sakamoto J, Sakamaki H. Early cytotoxic lymphocyte expansion contributes to a deep molecular response to dasatinib in patients with newly diagnosed chronic myeloid leukemia in the chronic phase: results of the D-first study. Am J Hematol. 2015 Sep;90(9):819-24. doi: 10.1002/ajh.24096.
Iriyama N, Fujisawa S, Yoshida C, Wakita H, Chiba S, Okamoto S, Kawakami K, Takezako N, Kumagai T, Inokuchi K, Ohyashiki K, Taguchi J, Yano S, Igarashi T, Kouzai Y, Morita S, Sakamoto J, Sakamaki H. Shorter halving time of BCR-ABL1 transcripts is a novel predictor for achievement of molecular responses in newly diagnosed chronic-phase chronic myeloid leukemia treated with dasatinib: Results of the D-first study of Kanto CML study group. Am J Hematol. 2015 Apr;90(4):282-7. doi: 10.1002/ajh.23923. Epub 2015 Mar 2.
Other Identifiers
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KCSG-03
Identifier Type: -
Identifier Source: org_study_id