Rapamycin in Relapsed Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Compare changes in gene expression signatures in steroid alone versus steroid plus rapamycin treated patients.
研究概览
简要总结
This is a research study designed to look at the biological effects of two drugs on leukemia cells. In this study, we are comparing the effects of drugs called corticosteroids when used alone or with another drug called rapamycin. Rapamycin is a drug that prevents the body's immune system from working normally. It has been used for many years after kidney transplants to prevent rejection of the organ. Recent work suggests that rapamycin may also help treat leukemia and other cancers.
详细描述
- Participants will be randomized into two groups; one group will receive corticosteroid alone, and the other group will receive rapamycin and corticosteroid.
- The length of treatment will be 5 days, during which time we will collect blood samples to measure the biologic effects of these drugs. Because these drugs will be given for a short period of time only, this study is not designed to treat or cure the participants leukemia. After the 5-day period, participants may resume other cancer-directed therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 365 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented acute lymphoblastic leukemia (L1 or L2 subtypes)
- •First or subsequent relapse
- •365 days of age or older
- •Greater than 7 days from any chemotherapy or immunotherapy, with the exception of intrathecal chemotherapy
- •Absolute peripheral leukemia blast count of 1000 cells/ul or greater
- •Patient (or parent/guardian if patient is less than 18 years of age) must sign informed consent
排除标准
- •Burkitts leukemia (acute lymphoblastic leukemia L3 subtype)
- •Uncontrolled active infection
- •Pregnancy or mothers who are nursing
- •Patient currently taking rapamycin
- •Patients with significant liver dysfunction as outlined in protocol
- •Severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into the study
- •Active psychiatric disease, substance abuse, or mental illness that would interfere with cooperation with the requirements of the trial
研究组 & 干预措施
Steroid Only
Corticosteroid Alone
干预措施: Corticosteroid (Drug)
Steroid plus Rapamycin
Corticosteroid plus Rapamycin
干预措施: Corticosteroid (Drug)
Steroid plus Rapamycin
Corticosteroid plus Rapamycin
干预措施: Rapamycin (Drug)
结局指标
主要结局
Compare changes in gene expression signatures in steroid alone versus steroid plus rapamycin treated patients.
时间窗: 3 years
Compare biologic measures of "pro-apoptotic state" in steroid alone versus steroid plus rapamycin treated patients
时间窗: 3 years
次要结局
- Assess clinical response by percent reduction of peripheral leukemia blasts at day 2 of therapy and at completion of the 5-day investigational window(3 years)
研究者
Lewis B. Silverman, M.D.
Principal Investigator
Dana-Farber Cancer Institute