JPRN-UMIN000005462已完成2 期
Efficacy of Imatinib with Early Dose Titration Targeting Optimal Blood Trough Levels in Patients with Chronic Myeloid Leukemia in Early Chronic Phase: A Phase II Study - Clinical Study Evaluating the Efficacy of Imatinib with Early Dose adjustment for Optimal Blood Trough Levels in Patients with CML-early CP
Tokyo CML Conference0 个研究点目标入组 100 人开始时间: 2011年4月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
- 年龄范围
- 16years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Failure to achieve complete hematologic response (CHR) at 3 months after the start of imatinib therapy. 2)Loss of CHR or complete cytogenetic response (CCyR) once achieved at any time after the start of imatinib therapy. 3)Development of any Bcr-Abl gene mutation that confers decreased sensitivity to imatinib. 4)Appearance of additive chromosomal aberration in a Ph chromosome positive cell at any time after the start of imatinib therapy. 5)Presence of the Bcr-Abl point mutation T351I. 6)Previous treatment with any investigational drug for CML. 7)Previous treatment with IFN-alpha. 8)Previous treatment with any oral cytotoxic drug (e.g., hydroxyurea) for at least 3 months. 9)Confirmed or potential pregnancy, current breast-feeding, and wish to have a child during the study period. 10)A history of allergy to imatinib. 11)Any other diffuse malignancy during the 5 years before enrollment. 12)Any serious or uncontrollable concomitant illness. 13)Any concomitant psychotic disorder or psychiatric symptom that, in the investigator's opinion, prevents the patient from participating in the study. 14)Cognitive dysfunction
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