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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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| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete molecular response (CMR) after treatment with dasatinib | 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. | by 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| complete molecular response (CMR) | by 3,6,12,24, 36 months | |
| Major Molecular Response(MMR) | by 3,6,12,18,24,36 months | |
| Complete Cytogenetic Response(CCyR) |
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Inclusion Criteria:
Exclusion Criteria:
A case with the double cancer of the activity
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
A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
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Patients with newly diagnosed chronic-phase chronic myelogenous leukemia in Japan
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takashi Kumagai, M.D, Ph.D | Contact | 81-428-22-3191 | kumamed1_2001@yahoo.co.jp | |
| Hisashi Sakamaki, M.D, Ph.D | Contact | 81-3-3823-2101 | sakamaki-h@cick.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto CML Study Group | Recruiting | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26103598 | Derived | 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. | |
| 25530131 |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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.
| by 6,12 months |
| Expansions rate of large granular lymphocyte | by 12 months |
| Progression free survival | at 36 months |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | by 36 months |
| Derived |
| 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. |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |