Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
NCT ID: NCT01627132
Last Updated: 2012-06-25
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
PHASE2
50 participants
INTERVENTIONAL
2012-02-29
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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dasatinib
Dasatinib
100mg QD
Interventions
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Dasatinib
100mg QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with BCR-ABL-negative checks.
* 15 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.
* Patients with complications or a history of severe.
* Patients with mutation of T315I、F317L、V299L.
* Patients with additional chromosome abnormalities.
* The case of Pleural effusion with poor control.
* Patients with a history of hematopoietic stem cell transplantation.
15 Years
ALL
No
Sponsors
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Epidemiological and Clinical Research Information Network
OTHER
Shimousa Hematology Study Group
OTHER
Responsible Party
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Koiti Inokuchi,MD,PhD.
Nippon Medical School
Principal Investigators
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Koiti Inokuchi
Role: PRINCIPAL_INVESTIGATOR
Nippon Medical School
Locations
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Nippon Medical School
Sendagi 1-1-5, Bunkyo-ku,Tokyo, Japan
Countries
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Central Contacts
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Facility Contacts
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References
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Kumagai T, Nakaseko C, Nishiwaki K, Yoshida C, Ohashi K, Takezako N, Takano H, Kouzai Y, Murase T, Matsue K, Morita S, Sakamoto J, Wakita H, Sakamaki H, Inokuchi K; Kanto CML, Shimousa Hematology Study Groups. Silent NK/T cell reactions to dasatinib during sustained deep molecular response before cessation are associated with longer treatment-free remission. Cancer Sci. 2020 Aug;111(8):2923-2934. doi: 10.1111/cas.14518. Epub 2020 Jun 26.
Other Identifiers
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SHSG-01
Identifier Type: -
Identifier Source: org_study_id
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