A Phase II Clinical Trial of Sapacitabine, Cyclophosphamide, and Rituximab (SCR) for Relapsed Patients With Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) and Deletion 11q22-23 by FISH
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The goal of this clinical research study is to learn if sapacitabine given in combination with 2 standard drugs (cyclophosphamide and rituximab) can help to control CLL and SLL. The safety of this drug combination will also be studied.
详细描述
The Study Drugs:
Sapacitabine and cyclophosphamide are designed to damage the DNA (genetic material) of cancer cells, which may cause the cancer cells to die.
Rituximab is designed to attach to cancer cells and damage them, which may cause the cancer cells to die. It is also designed to cause the immune system to attack cancer cells.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive sapacitabine by mouth 1 time a day on Days 1-3 of each 28-day cycle. Try to take sapacitabine at least 1 hour before or 2 hours after a meal. On Days 1-3 of each cycle, you will also receive cyclophosphamide by vein over 30 minutes, starting 2 hours after you take sapacitabine.
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
- •Patients must have a diagnosis of CLL/SLL and be previously treated
- •Patients must have had Fluorescence in situ Hybridization (FISH) evaluation of leukemia cells within 3 months without intervening treatment demonstrating deletion 11q22-23
- •Patients must have an indication for treatment by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
- •Age >/= 18 years
- •Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status </= 2
- •Adequate renal and hepatic function as indicated by all the following: serum creatinine </= 2 mg/dL AND; alanine aminotransferase (ALT) </= 2.5 times upper limit of normal; AND total bilirubin </= 2.5 times upper limit of normal
- •Patients must have an Absolute neutrophil count (ANC) >/= 500/uL, Hemoglobin (HGB) >/= 8 gm/dL, Platelets (PLT) count >/= 20K/uL, unless attributed to marrow infiltration with CLL
- •Patients must give written informed consent
- •Patients of childbearing potential (females who have not been postmenopausal for at least 12 consecutive months or who have not undergone previous surgical sterilization or males who have not been surgically sterilized) must be willing to practice birth control during the study
排除标准
- •Pregnant or breast-feeding females
- •Significant co-morbidity indicated by major organ system dysfunction
- •Active infection, uncontrolled with intravenous antibiotics
- •Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura (ITP)
- •Treatment including chemotherapy, chemoimmunotherapy, monoclonal antibody therapy, radiotherapy, high-dose corticosteroid therapy (prednisone >/= 60 mg daily, or equivalent), or immunotherapy within 3 weeks prior to enrollment or concurrent with this trial
研究组 & 干预措施
Cyclophosphamide, Rituximab + Sapacitabine
After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.
干预措施: Cyclophosphamide (Drug)
Cyclophosphamide, Rituximab + Sapacitabine
After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.
干预措施: Rituximab (Drug)
Cyclophosphamide, Rituximab + Sapacitabine
After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.
干预措施: Sapacitabine (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 84 days
Patients evaluated for response by 2008 International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] overall response criteria before course 4, then after every 2 courses, and at end of treatment (2 months after last course). Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR). Complete response is the absence of signs and symptoms, normalization of peripheral blood and bone marrow and lymph nodes 1.5 cm in diameter or smaller on CT scan. Partial response is at least 50% reduction in disease signs and symptoms, a 50% improvement in peripheral blood and greater than or equal to 50% reduction in lymph nodes.
次要结局
- Overall Survival(Up to 8.5 years)