Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan (D-First)
This study is currently recruiting participants.
Verified November 2011 by Kanto CML Study Group
Sponsor:
Kanto CML Study Group
Information provided by (Responsible Party):
Takashi Kumagai, Kanto CML Study Group
ClinicalTrials.gov Identifier:
NCT01464411
First received: September 18, 2011
Last updated: November 2, 2011
Last verified: November 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 18, 2011 | ||||||||
| Last Updated Date | November 2, 2011 | ||||||||
| Start Date ICMJE | July 2011 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Rate of complete molecular response (CMR) after treatment with dasatinib [ Time Frame: by 18 months ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01464411 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan | ||||||||
| Official Title ICMJE | Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase | ||||||||
| Brief Summary | The purpose of this study is to evaluate effectiveness of Dasatinib as the first line therapy for patients with newly diagnosed chronic myeloid leukemia in chronic phase in Japan. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: 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. |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients with newly diagnosed chronic-phase chronic myelogenous leukemia in Japan |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Months and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Japan | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01464411 | ||||||||
| Other Study ID Numbers ICMJE | KCSG-03 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Takashi Kumagai, Kanto CML Study Group | ||||||||
| Study Sponsor ICMJE | Kanto CML Study Group | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Kanto CML Study Group | ||||||||
| Verification Date | November 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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