Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 18
- 主要终点
- Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
研究概览
简要总结
This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dasatinib, 50 mg QD to 120 mg BID, Chronic phase
Participants with chronic phase disease continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID).
干预措施: Dasatinib (Drug)
Imatinib, 400 mg BID, Chronic phase
Participants with chronic phase disease received 400 mg of imatinib twice BID.
干预措施: Imatinib (Drug)
Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP
Participants with advanced phase disease, accelerated phase (AP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
干预措施: Dasatinib (Drug)
Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP
Participants with advanced phase disease, myeloid blast cell (MBP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
干预措施: Dasatinib (Drug)
Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL
Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
干预措施: Dasatinib (Drug)
结局指标
主要结局
Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest
时间窗: Day 1 of treatment through a maximum of 82 months + 30 days
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.
次要结局
未报告次要终点