EUCTR2007-007434-20-SE进行中（未招募）不适用
Phase I (II) study of the combination of lenalidomide and alemtuzumab in patients with chemotherapy refractory chronic lymphocytic leukemia (CLL)
Deptartment of Hematology, Karolinska University Hospital0 个研究点目标入组 25 人开始时间: 2007年12月28日最近更新:
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
- 25
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. Understand and voluntarily sign an informed consent form.
- •2. Age >=18 years at the time of signing the informed consent form.
- •3. Able to adhere to the study visit schedule and other protocol requirements.
- •4. Diagnosed with CLL and failed chemotherapy for CLL defined as refractory or relapsed with new need of treatment within 12 months after chemotherapeutic regimens in use for CLL therapy.
- •5. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to first treatment dose in this study.
- •6. ECOG performance status of <= 2 at study entry (see Appendix 1).
- •7. Laboratory test results within these ranges:
- •- Absolute neutrophil count >=0.5 x 109/L
- •- Platelet count >=25 x 109/L
- •- Serum creatinine 177 µmol/L
- •- Total bilirubin 26 µmol/L
- •- ASAT (SGOT) and ALAT (SGPT) <= 2 x ULN or <= 5 x ULN unless attributable to CLL
- •8. Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast.
- •9. Able to take aspirin (75 or 160 mg) daily as prophylactic anticoagulation, unless patients intolerant to ASA may use low molecular weight heparin. If platelet count < 50 x 109/L, prophylactic anticoagulation should not be given.
- •10. 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 breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- •3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •4. Use of any other experimental therapy within 28 days of baseline.
- •5. Any prior use of lenalidomide or thalidomide.
- •6. Concurrent use of other anti-cancer agents or treatments.
- •7. Known positive for HIV or infectious hepatitis, type A, B or C.
- •8. Opportunistic infections within the last 4 months.
- •9. Previous alemtuzumab therapy within the last 4 months.
- •10. Renal impairment, defined as calculated creatinine clearance below 60mL/min as defined by the method of Cockroft-Gault.
- •11. Evidence of pre-existing TLS per the Cairo-Bishop definition of laboratory TLS(Subjects may be enrolled upon correction of electrolyte abnormalities).
- •12. History of renal failure requiring dialysis.
- •13. Uncontrolled hemolytic anemia or autoimmune thrombocytopenia.
研究者
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