Dasatinib versus nilotinib as upfront therapy for treatment naïve chronic myeloid leukemia chronic phase
<p>This is a randomized, phase 3 clinical trial comparing ’head to head’ nilotinib versus dasatinib as upfront therapy for patient with chronic myeloid leukemia. The efficacy of both drugs will be tested by measuring BCR/ABL using European LeukemiaNet recommendations. The study will be conduct...
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2021
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| Summary: | <p>This is a randomized, phase 3 clinical trial comparing ’head to head’ nilotinib versus dasatinib as upfront therapy for patient with chronic myeloid leukemia. The efficacy of both drugs will be tested by measuring BCR/ABL using European LeukemiaNet recommendations. The study will be conducted in the National Center for Cancer Care & Research (NCCCR).</p> <p>Adult patients will be eligible within 6 months after the diagnosis of Philadelphia chromosome positive Chronic Myeloid Leukemia in the chronic phase. Diagnosis will be determined by conventional cytogenetic analysis of bone marrow containing at least 1 Philadelphia chromosome–positive metaphase cell. The definition of chronic-phase Chronic Myeloid Leukemia as per WHO 2016. Patients will be recruited from hematology outpatient department or in-patient wards after confirmation of the diagnosis; vulnerable subjects will be excluded from the study.</p> <p>The primary efficacy end point will be the rate of major molecular response at 12 months, defined as a BCR-ABL transcript level of 0.1% or less in peripheral blood on RQ-PCR assay, as expressed on the International Scale. This corresponds to a reduction of 3 log10 copies or more in BCR-ABL transcripts, as compared with the standardized baseline established in IRIS.</p> <p>The key secondary end point will be a durable major molecular response by 24 months. Furthermore, for this study, the rate of complete cytogenetic response by 12 months will be the main secondary end point.</p> <p>This trial is registered in ClinicalTrials.gov with number NCT03079505. Protocol version: August 2017</p> <h2>Other Information</h2> <p>Published in: Medicine Case Reports and Study Protocols<br> License: <a href="https://creativecommons.org/licenses/by/4.0/" target="_blank">https://creativecommons.org/licenses/by/4.0/</a><br> See article on publisher's website: <a href="http://dx.doi.org/10.1097/md9.0000000000000061" target="_blank">http://dx.doi.org/10.1097/md9.0000000000000061 </a></p> |
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