Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan (D-First)
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|ClinicalTrials.gov Identifier: NCT01464411|
Recruitment Status : Unknown
Verified November 2011 by Takashi Kumagai, Kanto CML Study Group.
Recruitment status was: Recruiting
First Posted : November 3, 2011
Last Update Posted : November 3, 2011
|Condition or disease|
|Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelogenous Leukemia, Chronic, Chronic Phase|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase|
|Study Start Date :||July 2011|
- Rate of complete molecular response (CMR) after treatment with dasatinib [ Time Frame: by 18 months ]The rate(%) of patients who achieve complete molecular response (CMR) by 18 months after the dasatinib therapy will be measured to evaluate the efficiency of dasatinib.
- complete molecular response (CMR) [ Time Frame: by 3,6,12,24, 36 months ]
- Major Molecular Response(MMR) [ Time Frame: by 3,6,12,18,24,36 months ]
- Complete Cytogenetic Response(CCyR) [ Time Frame: by 6,12 months ]
- Expansions rate of large granular lymphocyte [ Time Frame: by 12 months ]
- Progression free survival [ Time Frame: at 36 months ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: by 36 months ]
Biospecimen Retention: Samples With DNA
Copy numbers of bcr-abl mRNA in patients with dasatinib treatment will be measured by real-time RT-PCR to evaluate the efficiency of dasatinib.
For patients resistant to dasatinib therapy, DNA mutation analysis of the bcr-abl gene associated with drug-resistancy will be performed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464411
|Contact: Takashi Kumagai, M.D, Ph.Dfirstname.lastname@example.org|
|Contact: Hisashi Sakamaki, M.D, Ph.Demail@example.com|