A Phase I/II Clinical Trial of Fludarabine, Bendamustine, and Rituximab (FBR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)
研究概览
简要总结
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of bendamustine, combined with fludarabine and rituximab, that can be given to patients who have CLL that has been treated before.
The goal of Phase 2 of this study is to find out if this drug combination can help to control the disease. The safety of this drug combination will also be studied.
详细描述
The Study Drugs:
Fludarabine and bendamustine 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 Dose Levels:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. One (1) to 8 groups with 3-6 participants will be enrolled in the Phase 1 portion of the study, and up to 58 participants will be enrolled in Phase 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, 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/Small Lymphocytic Lymphoma (SLL) and be previously treated
- •Patients must have an indication for treatment by 2008 IWCLL Criteria
- •Age >/= 16 years
- •Zubrod performance status </= 2
- •Adequate renal and hepatic function as indicated by all the following: a. serum creatinine </= 2 mg/dL AND; b. alanine aminotransferase (ALT) </= 2.5 times upper limit of normal AND; c. total bilirubin </= 2.5 times upper limit of normal
- •Patients must give written informed consent
- •Patients of childbearing potential 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, uncontrolled infection, including active hepatitis
- •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 21 days prior to enrollment or concurrent with this trial
研究组 & 干预措施
Phase 1 20 mg/m^2
Bendamustine, Fludarabine + Rituximab
干预措施: Rituximab (Drug)
Phase 1 20 mg/m^2
Bendamustine, Fludarabine + Rituximab
干预措施: Bendamustine (Drug)
Phase 1 20 mg/m^2
Bendamustine, Fludarabine + Rituximab
干预措施: Fludarabine (Drug)
Phase 2
Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab
干预措施: Bendamustine (Drug)
Phase 2
Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab
干预措施: Fludarabine (Drug)
Phase 2
Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab
干预措施: Rituximab (Drug)
Phase 1 30 mg/m^2
Bendamustine, Fludarabine + Rituximab
干预措施: Bendamustine (Drug)
Phase 1 30 mg/m^2
Bendamustine, Fludarabine + Rituximab
干预措施: Fludarabine (Drug)
Phase 1 30 mg/m^2
Bendamustine, Fludarabine + Rituximab
干预措施: Rituximab (Drug)
Phase 1 40 mg/m^2
Bendamustine, Fludarabine + Rituximab
干预措施: Bendamustine (Drug)
Phase 1 40 mg/m^2
Bendamustine, Fludarabine + Rituximab
干预措施: Fludarabine (Drug)
Phase 1 40 mg/m^2
Bendamustine, Fludarabine + Rituximab
干预措施: Rituximab (Drug)
Phase 1 50 mg/m^2
Bendamustine, Fludarabine + Rituximab
干预措施: Bendamustine (Drug)
Phase 1 50 mg/m^2
Bendamustine, Fludarabine + Rituximab
干预措施: Fludarabine (Drug)
Phase 1 50 mg/m^2
Bendamustine, Fludarabine + Rituximab
干预措施: Rituximab (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)
时间窗: After 4 week cycle
MTD defined as highest dose level in which 6 participants have been treated with \</= to 1 patient experiencing dose limiting toxicity (DLT). MTD exceeded if 2 or more of 6 patients experience grade 3 or higher, non-hematologic, non-infusion related toxicity a major organ system. DLT defined as treatment-related, grade \>/= 3 non-hematologic toxicity. Hematologic toxicity grade \>/= 3 that lasts longer than 42 days considered a DLT. Hematologic toxicity graded according to the 2008 IWCLL criteria for grading. Tumor lysis not considered a DLT.
次要结局
- Overall Response Rate of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)(Overall response assessed 2 months after 6th or last course if participants not able to receive all 6 intended courses of treatment.)