EUCTR2006-004469-32-IT进行中（未招募）不适用
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF TWO LENALIDOMIDE DOSE REGIMENS IN SUBJECTS WITH RELAPSED OR REFRACTORY B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA - CC-5013-CLL-001
CELGENE CORPORATIO0 个研究点目标入组 340 人开始时间: 2008年1月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Must understand and voluntarily sign an informed consent form. 2. Age > 18 years at the time of signing the informed consent form. 3. Must be able to adhere to the study visit schedule and other protocol requirements. 4. Must have a documented diagnosis of B-cell CLL (NCI-WG criteria) that has relapsed after or is refractory to at least one prior regimen. The prior treatment regimen(s) must have included: a. An alkylating agent (e.g., chlorambucil or cyclophosphamide) and; b. Fludarabine (subjects must have failed to achieve at least a partial response lasting for 12 months (after completion of the last treatment cycle) to their most recent fludarabine-containing regimen). 5. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of * 2. 6. Females of childbearing potential (FCBP)? must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner?s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. Pregnant or lactating females. 3. Systemic treatment for B-cell CLL within 28 days of randomization. 4. Subjects with central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging; subjects with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks prior to randomization. 5. Prior history of malignancy other than CLL (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for 3 years. 6. Known HIV-1 positivity. 7. Prior therapy with lenalidomide. 8. Any of the following laboratory abnormalities: (a) ANC < 500/μL (0.5 X 109/L) (b) Platelet count < 25,000/μL (25 x 109/L) (c) Serum creatinine > 2.5 mg/dL (d) Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN) (d) Serum total bilirubin > 2.0 mg/dL 9. Prior allergic reaction to thalidomide. 10. Prior desquamating (blistering) rash while taking thalidomide. 11. Peripheral neuropathy grade 2. 12. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia. 13. Richter?s transformation (active).
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