Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan (D-First)
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464411
|Contact: Takashi Kumagai, M.D, Ph.Demail@example.com|
|Contact: Hisashi Sakamaki, M.D, Ph.Dfirstname.lastname@example.org|