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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This study is conducted in patients with newly diagnosed CP CML (Chronic Phase Chronic Myeloid Leukemia) who have achieved EMR (< 10% IS BCR-ABL) at 3 months after first line treatment with dasatinib. Subjects will be allocated to 80mg QD based on EMR (Early Molecular Response) achievement and early safety profile following a standard of care approach.
Patients will sign the consent forms for screening prior to frontline dasatinib therapy (1st) and the 3 month molecular test date (2nd). The molecular samples will be analyzed in the central lab as part of the screening procedure.
Subjects will be treated for a maximum of 60 months after allocation of the last subject on the assigned regimen (dasatinib 80mg QD), unless disease progression, treatment failure or unacceptable toxicity occurs, the subject withdraws consent, or the study is discontinued by the sponsor. Subjects who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to 5 years after allocation of the last subject. All subjects will be followed yearly for progression-free survival and overall survival.
For patients who continue their assigned treatment, safety assessments will be conducted every 6 months and cytogenetic assessment as investigator assessment.
Follow up visits after the last dose of study drug will be required at least every 4 weeks until all study related toxicities resolve to baseline (or CTC Grade ≤ 1), stabilize or are deemed irreversible.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RQ-PCR(Real-time Quantitative Polymerase chain reaction) RNA Analysis | Other | Conventional Q-RT-PCR every 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of MMR | Level of Bcr-Abl transcript (Conventional Q-RT-PCR) | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| To assess: Number and percentage of participants with treatment-related adverse events as assessed by CTCAE v4.0. | Safety | 12 months |
| MMR and MR4.5 rates by 5 years | Level of Bcr-Abl transcript (Conventional Q-RT-PCR) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult CML-CP Ph+ patients with BCR-ABL1 will start frontline dasatinib 100mg QD treatment. Dasatinib monotherapy must have been started within 3 months of CP-CML diagnosis. Patients having BCR-ABL1 transcript level < 10% IS (International Standard) after 3 months of treatment with frontline dasatinib will reduce dasatinib dose to 80mg QD and all of patients must have any grade of adverse events at 3 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong-Wook Kim | Contact | +82-2-2258-7030 | dwkim@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sahee Park | Cancer Research Institute, The Catholic University of Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital | Recruiting | Seoul | 137-701 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27217448 | Result | Cortes JE, Saglio G, Kantarjian HM, Baccarani M, Mayer J, Boque C, Shah NP, Chuah C, Casanova L, Bradley-Garelik B, Manos G, Hochhaus A. Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients Trial. J Clin Oncol. 2016 Jul 10;34(20):2333-40. doi: 10.1200/JCO.2015.64.8899. Epub 2016 May 23. |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Rest of RNA samples after Q-RT-PCR (Quantitative Real-time Polymerase chain reaction) analysis
| 5 years |
| 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 |