CTRI/2022/03/041208尚未招募未知
Comparison of Efficacy & Safety of Dasatinib versus Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia with Reference to Early Molecular Response An Exploratory Study
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Study Population: Newly diagnosed chronic phase chronic myeloid leukemia patients who fulfil inclusion criteria will be enrolled in the study.
- •Inclusion Criteria:
- •Newly diagnosed patients with chronic phase CML.
- •Age >= 12 years, both males & females.
- •Patients willing to provide written informed consent.
排除标准
- •Exclusion Criteria:
- •Patients with de novo accelerated phase or blast phase CML.
- •Patients who have already started any tyrosine kinase inhibitor (TKI) treatment prior to randomization (Hydroxyurea started for initial cytoreduction is permitted).
- •Pregnancy.
- •Lactation.
- •Patients with pre-existing pleural effusion, grade >= 3 lung disease, or pulmonary arterial hypertension.
- •Patients with angina, or grade >= 3 cardiac disease[as defined by the New York Heart Association (NYHA) criteria] at diagnosis.
- •Patients with prolonged QTc interval ( > 480 msec) at baseline, or taking any concomitant medication known to prolong QTc interval.
研究者
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