EUCTR2006-004469-32-FR进行中（未招募）1 期
A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF TWO LENALIDOMIDE DOSE REGIMENS IN SUBJECTS WITH RELAPSED OR REFRACTORY B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- •Must understand and voluntarily sign an informed consent form.
- •Must be =18 years of age at the time of signing the informed consent form.
- •Must be able to adhere to the study visit schedule and other protocol requirements.
- •Must have a documented diagnosis of B-cell CLL (NCI-WG criteria, Appendix 21.4) that has relapsed after or is refractory to at least one prior regimen. The prior treatment regimen(s) must have included:
- •- An alkylating agent (e.g., chlorambucil or cyclophosphamide) and;
- •- Fludarabine (subjects must have developed disease progression within 12 months (of the completion of the last treatment cycle) of their most recent fludarabine-containing regimen).
- •Must have an Eastern Cooperative Oncology Group (ECOG) performance
- •status score of = 2.
- •Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual intercourse during the 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.
- •Before starting study drug:
- •Female Subjects:
- •FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10 – 14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative.
- •Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure.
- •Must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from the study.
- •Male Subjects:
- •Must agree to use a latex condom during any sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if they have undergone a successful vasectomy.
- •Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure.
- •Must agree to abstain from donating blood, semen or sperm during study participation and for 28 days after discontinuation from the study.
- •During study participation and for 28 days following discontinuation from the study:
- •All Subjects:
- •No more than a 28 day supply of study drug will be dispensed at a time.
- •Female Subjects:
- •FCBP with regular cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following discontinuation from the study. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following discontinuation from the study.
- •In addition
排除标准
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Pregnant or lactating females.
- •Systemic treatment for B-cell CLL within 28 days of randomization.
- •Subjects with central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging and subjects with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within two weeks prior to randomization.
- •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.
- •Known HIV-1 positivity.
- •Prior therapy with lenalidomide.
- •Any of the following laboratory abnormalities:
- •- ANC < 500/µL (0.5 X 10 e9/L)
- •- patelet count < 25,000/µL (25 x 10e9/L)
- •- Calculated (method of Cockroft-Gault) creatinine clearance <50 mL/min
- •- 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)
- •- Serum total bilirubin > 2.0 mg/dL
- •Prior allergic reaction to thalidomide.
- •Prior desquamating (blistering) rash while taking thalidomide.
- •= Grade-2 neuropathy.
- •Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
- •Richter’s Transformation (active)
研究者
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