A Phase II, Multicentre Study of Oral LBH589 in Patients With Accelerated Phase or Blast Phase (Blast Crisis) Chronic Myeloid Leukemia With Resistant Disease Following Treatment With at Least Two BCR-ABL Tyrosine Kinase Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 20
- 主要终点
- Participants With Hematologic Response
研究概览
简要总结
This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
详细描述
study was designed to assess the hematologic response associated with treatment of oral panobinostat. Hematologic response is defined as the overall of complete hematologic response (CHR), and of no evidence of leukemia (NEL) and of the return to chronic phase (RTC). Hematologic responses were to be confirmed after 4 weeks, and all criteria listed below for each type of response were to be concomitantly met to result into a response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
Panobinostat
Participants received panobinostat 20 milligrams (mg) orally once daily (OD), three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat was administered at the same time each morning, and with an 8oz/240 milliliter (ml) of water after a fasting period of at least two hours (water was allowed). Participants could continue this treatment until an unacceptable toxicity that precludes further treatment was experienced, or until disease progression.
干预措施: LBH589 (Drug)
结局指标
主要结局
Participants With Hematologic Response
时间窗: From Start of the Study up to Study Termination (approximately up to 18 Months).
The primary efficacy variable was hematologic response, a composite endpoint defined as the overall of complete hematologic response (CHR), and of no evidence of leukemia (NEL) and of the return to chronic phase (RTC).
次要结局
- Major (Complete/Partial) Cytogenetic Response Rate(From Start of the Study up to Study Termination (approximately up to 18 Months).)
- Major (MMR) and Complete (CMR) Molecular Response Rates(From Start of the Study up to Study Termination (approximately up to 18 Months).)
- Duration of Hematologic Response(From Start of the Study up to Study Termination (approximately up to 18 Months).)
- Complete Cytogenetic Response (CCyR) and Overall (Complete/Partial/Minor/Minimal) Cytogenetic Response (OCyR) Rates(From Start of the Study up to Study Termination (approximately up to 18 Months).)
- Duration of Major Cytogenetic Response(From Start of the Study up to Study Termination (approximately up to 18 Months).)
- Overall Survival Time(From Start of the Study up to Study Termination (approximately up to 18 Months).)
- Last Observed Plasma Concentration (Clast) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- Time of Clast (Tlast) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- Complete Cytogenetic Response (CCyR) Rate(From Start of the Study up to Study Termination (approximately up to 18 Months).)
- BCR-ABL Mutations of Participants at Study Entry and, in Responding Participants and at the Time of Disease Progression(From Start of the Study up to Study Termination (approximately up to 18 Months).)
- Progression Free Survival (PFS)(From Start of the Study up to Study Termination (approximately up to 18 Months).)
- Time to Peak Concentration (Tmax) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- Maximum Plasma Concentration (Cmax) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- Area Under the Plasma Concentration (AUC0-24) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- QT Interval (QTc) in Participants Receiving Oral Panobinostat at Baseline and Change From Baseline to Extreme Value(From Start of the Study up to Study Termination (approximately up to 18 Months).)
- Safety and Tolerability of Panobinostat(From Start of the Study up to Study Termination (approximately up to 18 Months).)