Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Maximum tolerable dose
研究概览
简要总结
Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
详细描述
Rationale:
Lenalidomide has properties of thalidomide and appears to have some activity against cancer in laboratory tests. Researchers are still learning how lenalidomide works against cancer in patients. Some ways that this drug seems to produce anti-cancer effects include through stimulating the immune system and blocking blood vessels contributing to cancer growth. The current study will explore different dose levels in patients to gather more information about lenalidomide.
Purpose:
This study will assess the maximum tolerated dose of lenalidomide in patients with relapsed or refractory acute leukemias and chronic lymphocytic leukemias. Toxicity or side effects within patients will also be evaluated. Other purposes of this study include analyzing preliminary clinical activity, pharmacokinetics, and pharmacodynamics. Pharmacokinetics refers to the activity of drugs in the body over a period of time, including how drugs are absorbed, distributed, localized in tissues, and excreted. Pharmacodynamics refers to the bodily processes that lead the drug to effect cancer and other cellular components in the body.
Treatment:
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
- •Blood blast count must be < 40,000/uL prior to initiation of therapy. Hydroxyurea (up to 6g/day) may be administered prior to initiation of therapy and during the first week to maintain blood blast count < 40,000/uL
- •ECOG(Eastern Cooperative Oncology Group)performance status 0-
- •Patients with CNS(central nervous system)involvement will be considered eligible for this study if no residual leukemic cells are detected in the CSF (cerebrospinal fluid)following intrathecal chemotherapy or radiation.
排除标准
- •Patients with acute promyelocytic leukemia are excluded unless patient has failed salvage therapy with arsenic.
- •Patients with HIV are excluded due to increased risk of infectious complications, marrow suppression, and potential interactions with antiviral therapy.
- •CLL patients who have had chemotherapy (with the exception of hydroxyurea) or radiotherapy within 4 weeks prior to entering the study are excluded. CLL patients receiving corticosteroids (within 2 weeks) for treatment of disease (other than autoimmune manifestations of CLL) are not eligible.
- •Patients who have received mitomycin C or nitrosourea require a six weeks recovery period before they can be enrolled on the current study.
- •Patients with the following abnormal clinical values are excluded (unless abnormalities in these parameters are directly attributable to malignancy): Serum creatinine >2.0 mg/dl Total bilirubin > 2 x upper limit of normal (unless due to Gilbert's syndrome) ALT and AST > 5 x upper limit of normal
研究组 & 干预措施
Stratum 1 Acute Leukemias
Patients must have a diagnosis of Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia(ALL)according to the WHO (World Health Organization) classification.
干预措施: lenalidomide (Drug)
Stratum 2 Chronic lymphocytic leukemia
Patients must have diagnosis of B-Cell, Chronic Lymphocytic Leukemia(CLL) or Small Lymphocytic Leukemia (SLL) (including Waldenstrom's Macroglobulinemia) requiring therapy (see eligibility criteria for definition of this) and have previously received treatment with one or more prior chemotherapy regimens.
干预措施: lenalidomide (Drug)
结局指标
主要结局
Maximum tolerable dose
时间窗: Every 2 weeks during cycle 1; Monthly during subsequent cycles
Toxicities of lenalidomide
时间窗: Every 2 weeks during cycle 1; Monthly for subsequent cycles
次要结局
- pharmacodynamics(Days 1, 8 and 26.)
- preliminary clinical activity(Twice weekly during cycle 1; Weekly during cycles 2-6; Monthly thereafter)
- plasma and cellular pharmacokinetics(Days 1, 8, 15 and 21 of first cycle.)
研究者
Leslie Andritsos
Principal Investigator
Ohio State University Comprehensive Cancer Center