Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) With IPI-145
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The goal of this clinical research study is to learn if IPI-145 can help to control the disease in patients with ALL. The safety of the study drug will also be studied.
详细描述
Study Drug Administration:
If patient is found to be eligible to take part in this study, they will receive IPI-145 by mouth twice a day for a month (30 days). Patient should swallow IPI-145 whole with a glass of water (about 8 ounces). If patient forgets to take a dose or if they vomit, they should not take another dose.
Each study cycle lasts 30 days.
Patient's dose of the study drug may change depending on any side effects they may have.
Study Visits:
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously treated ALL (including Burkitt's lymphoma, lymphoblastic lymphoma) in relapse or primary refractory. Patients with ALL or B or T cell origin may be treated. Patients in first relapse will be eligible regardless of the first remission duration. At least 10 patients in Salvage 1-2 will be treated to assess anti-ALL response more precisely.
- •Age 16 years or older. Pediatric patients (<16 years old) will be allowed into the study after safety is established, that is at least 10 adult patients having received 1 or more cycles each.
- •Zubrod performance status 0-
- •Adequate liver function (bilirubin </= 1.5 mg/dL and SGPT or SGOT </= 3 x upper limit of normal [ULN], unless considered due to tumor), and renal function (creatinine </= 2 mg/dL). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 2.0 mg/dL and creatinine </= 3 mg/dL.
- •Male and female patients who are of childbearing potential agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 14 days of study start (applies only if patient is of childbearing potential. Non-childbearing is defined as > 1 year postmenopausal or surgically sterilized).
排除标准
- •Patient with active heart disease (NYHA class >/= 3 as assessed by history and physical examination).
- •Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) < 45% are excluded.
- •Patients who receive other chemotherapy. Patients must have been off previous therapy for >/= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing). (Concurrent therapy for central nervous system [CNS] prophylaxis or treatment for CNS relapse is permitted). Treatment may start earlier if necessitated by the patient's medical condition (e.g. rapidly progressive disease) following discussion with the Principal Investigator.
- •Prior allogeneic stem cell transplant in previous 3 months.
- •Peripheral lymphoblasts > 50 x 109/L.
- •Pregnant and breast-feeding patients are excluded.
- •Patients with known hepatitis B or C are excluded.
研究组 & 干预措施
IPI-145
IPI-145 given at dose of 75 mg orally twice daily for 4 weeks. Courses repeated about every 4 weeks (range 4-6 weeks).
干预措施: IPI-145 (Drug)
IPI-145
IPI-145 given at dose of 75 mg orally twice daily for 4 weeks. Courses repeated about every 4 weeks (range 4-6 weeks).
干预措施: Follow-up Visit/Call (Behavioral)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 60 days
Primary endpoint for efficacy is overall response rate (ORR) defined as complete remission (CR), complete remission without recovery of counts (CRi), or partial remission (PR). Overall response evaluated at the end of the first two cycles.
次要结局
未报告次要终点