NCT01005979终止1 期
A Phase I Trial Using Cyclophosphamide, Rituximab and Revlimid (CR2) for the Treatment of Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL) and SLL
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The primary endpoint is to determine the maximum tolerated dose of lenalidomide in combination with cyclophosphamide and rituximab for the treatment of CLL or SLL.
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose (MTD), safety and toxicity when cyclophosphamide, rituximab and lenalidomide (Revlimid) are combined for the treatment of relapsed/refractory of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Understand and voluntarily sign an informed consent form.
- •Age ≥ 18 years at the time of signing the informed consent form.
- •Able to adhere to the study visit schedule and other protocol requirements.
- •Relapsed/refractory B-cell CLL or SLL
- •All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 2 weeks prior to treatment in this study.
- •Patients must have received at least one prior therapy and must meet the NCI Working Group (NCI WG) Criteria for treatment of B-CLL as described in Appendix D.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at study entry (see Appendix C).
- •Laboratory test results within these ranges (unless related to CLL involvement):
- •Absolute neutrophil count ≥ 1000 /mm3
- •Platelet count ≥ 50,000/mm³
- •Serum creatinine ≤ 1.5 mg/dL. Serum creatinine > 1.5 mg/dL requires creatinine clearance of ≥ 60 mL/min by Cockroft-Gault formula.
- •Total bilirubin ≤ 1.5 mg/dL
- •Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 2 x upper limit of normal (ULN) or ≤ 5 x ULN if hepatic metastases are present.
- •Disease free of second malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.
- •Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International Units (mIU)/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix B: Education and Counseling Guidance Document.
- •Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin).
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 breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- •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.
- •Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop criteria (Appendix J) (subjects may be enrolled upon correction of electrolyte abnormalities).
- •Use of any other experimental drug or therapy within 28 days of baseline.
- •Known hypersensitivity to thalidomide.
- •The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •Any prior use of lenalidomide.
- •Concurrent use of other anti-cancer agents or treatments.
- •Known positive for HIV or infectious hepatitis, type A, B or C.
研究组 & 干预措施
A
Experimental
干预措施: Lenalidomide, Rituximab, and Cyclophosphamide (Drug)
结局指标
主要结局
The primary endpoint is to determine the maximum tolerated dose of lenalidomide in combination with cyclophosphamide and rituximab for the treatment of CLL or SLL.
时间窗: Day 28 of the first cycle of chemotherapy
次要结局
- Assess response criteria, including complete response rate, survival at 1 year, time to progression, duration of response, and eradication of minimal residual disease.(Response will be measured after 4 cycles, at the end of treatment and then every 3 months post treatment.)
研究者
Christopher R. Flowers
Principal Investigator
Emory University
研究点 (1)
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