EUCTR2006-004469-32-GB进行中（未招募）1 期
A PHASE 1/2, MULTI-CENTER,OPEN LABEL STUDY OF THE SAFETY AND EFFICACY OF A STEPWISE DOSE-ESCALATION SCHEDULE OF LENALIDOMIDE MONOTHERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 124
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
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 either during fludarabine-containing treatment or within 12 months 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)
- •- Have a negative medically supervised pregnancy test prior to starting of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy (see specifics in Appendix 21.6). This applies even if the subject practices complete and continued sexual abstinence.
- •- Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy (see specifics in Appendix 21.6).
- •Male subjects must:
- •- Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy (See specifics in Appendix 21.6).
- •- Agree to not donate semen or sperm during study drug therapy and for a period after end of study drug therapy (see specifics in Appendix 21.6).
- •All subjects must:
- •- Have an understanding that the study drug could have a potential teratogenic risk.
- •- Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy (see specifics in Appendix 21.6).
- •- Agree not to share study medication with another person.
- •- All subjects must be counseled about pregnancy precautions and risks of fetal exposure (See Appendix 21.6 of the protocol).
- •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
- •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 initiation of lenalidomide treatment.
- •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.
- •History of renal failure requiring dialysis.
- •Known HIV-1 positivity.
- •Prior therapy with lenalidomide.
- •Alemtuzumab therapy within 56 days of initiation of lenalidomide treatment.
- •Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities)
- •Any of the following laboratory abnormalities:
- •- ANC < 1000/µL (1.0 X 10 e9/L)
- •- Platelet count < 50,000/µL (50 x 10e9/L)
- •- Calculated (method of Cockroft-Gault) creatinine clearance <60 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)
- •Participation in and clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy
- •Known presence of alcohol and/or drug abuse
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