A Phase 2 Clinical Trial To Evaluate The Immune Restoration Potential Of Lenalidomide For Patients With CLL-Associated Immunodeficiency
概览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Immunoglobulin G level
概览
简要总结
This is phase 2 study of the immunomodulatory drug, lenalidomide, to evaluate potential beneficial effects on the immune system of patients with chronic lymphocytic leukemia (CLL) and CLL-associated immunodeficiency. 17 patients will be enrolled with CLL, small lymphocytic lymphoma (SLL), or monoclonal B-cell lymphocytosis (MBL), and measurable immune compromise, but not an iwCLL indication for CLL therapy (ie non-progressive disease).
详细描述
This is phase 2 study of the immunomodulatory drug, lenalidomide, to evaluate potential beneficial effects on the immune system of patients with chronic lymphocytic leukemia (CLL) and CLL-associated immunodeficiency. 17 patients will be enrolled with CLL, small lymphocytic lymphoma (SLL), or monoclonal B-cell lymphocytosis (MBL), and measurable immune compromise, but not an iwCLL indication for CLL therapy (ie non-progressive disease). Lenalidomide will be administered orally for 21 days of each 28 day cycle, starting at a 2.5mg dose, with dose escalation each cycle to a maximum of 25mg in the absence of any grade 2 or higher hematologic or non-hematologic adverse events. Treatment duration to primary endpoint assessment is 6 cycles, though patients will not be restricted from continuing lenalidomide off-study, if clinically indicated
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
- •Clinical and phenotypic verification of B cell CLL/ SLL/ or MBL and measurable disease.
- •Subjects must have total serum IgG \< 500 mg/dL
- •Disease Status/ Prior Therapy: There is not any requirement nor restriction for prior therapy.
- •Recovered from the toxic effects of prior therapy to their clinical baseline.
- •Both men and women of all races and ethnic groups are eligible for this trial.
- •Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. Both men and women must agree to use a barrier method of contraception for the duration of the study and until 8 weeks after the final dose of lenalidomide.
- •ECOG performance status of 0-
- •Adequate hematologic function:
- •Platelet count ≥ 50,000/µL; AND 8.
- •Hemoglobin ≥ 8.0 g/dL 8.
排除标准
- •Progressive CLL requiring therapy based on 2008 international working group guidelines (iwCLL 2008, Hallek et al, Blood 2008).
- •Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies.
- •Known hypersensitivity to thalidomide or lenalidomide.
- •Prior lenalidomide-associated deep vein thrombosis
- •Deep vein thrombosis or superficial thrombophlebitis of any cause on current anticoagulation therapy at the time of screening.
- •Patients who are currently receiving another investigational agent are excluded.
- •Patients who have had chemotherapy (e.g., purine analogues, alkylating agents), radiation therapy, tyrosine kinase inhibitor therapy, or participation in any investigational drug treatment within 4 weeks of initiation of lenalidomide or at any time during the study.
- •Patients who have had prior (within 8 weeks of initiation of lenalidomide) or concurrent antibody therapy directed against CLL.
- •Current infection requiring parenteral antibiotics.
- •Known seropositive for or active viral infection with human immunodeficiency virus (HIV); or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) based on detectable viral load. Patients who are seropositive because of hepatitis B virus vaccine are eligible.
研究组 & 干预措施
Lenalidomide
Lenalidomide is administered orally once daily on Days 8-28 of each 28 day cycle. The typical starting dose is 2.5mg PO daily. At the start of each cycle, there is intra-patient dose-escalation to a maximum of 25mg daily, in the absence of grade 2 or higher adverse events.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Immunoglobulin G level
时间窗: 2 years
IgG levels during and at the completion of 6 months of lenalidomide
次要结局
- Progression free survival rate at 6 months, determined by International Working Group in CLL (iwCLL) criteria.(2 years)
- Treatment-emergent adverse events, including infections(2 years)
研究者
Michael Choi
Assistant Clinical Professor
University of California, San Diego