A Post-Marketing Surveillance Study on the Safety And Effectiveness of Bendamustine Hydrochloride Among Adult Filipino Patients With Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of patients with incidence of adverse events
研究概览
简要总结
The purpose of this study is to assess safety and effectiveness of extended bendamustine in the treatment of chronic lymphocytic leukemia (CLL).
详细描述
This is a Phase IV, open label (all people know the identity of the intervention), multi-center, observational (a scientific study to make a clear and easy understanding of the cause and effect relationship) study of bendamustine. The study duration is of 24 Weeks to coincide with the 4 weeks-6 cycles bendamustine treatment. The study will run for three years, and will enroll 10 percent of patient who would use this product, as a requirement of the Philippine Food and Drug Administration (FDA). Approximately fifty patients will be enrolled in this study. Safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult Filipino patients with chronic lymphocytic leukemia
- •Patients who are cytologically-diagnosed with chronic lymphocytic leukaemia (symptomatic Binet stage B or C) and for whom fludarabine combination chemotherapy is not appropriate
- •World health organization performance Status of 0, 1, or 2
- •Need-to-treat criteria in B-cell chronic lymphocytic leukemia
排除标准
- •Had received previous treatment with other cytotoxic drugs
- •Had a history of a second malignancy (except cured basal cell carcinoma or cured cervical cancer)
- •Concomitant illnesses such as overt heart failure, cardiomyopathy, myocardial infarction within the last 6 months, severe uncontrolled diabetes mellitus, severe uncontrolled hypertension, active infection that required systemic antibiotic treatment in an investigational drug study within 30 days prior to selection
- •Patients with severe renal and hepatic impairment
- •Patients with severe bone marrow suppression and severe blood count alterations
- •Pregnant women and lactating mothers
研究组 & 干预措施
Bendamustine hydrochloride
Adult Filipino patients with chronic lymphocytic leukemia will be taking bendamustine hydrochloride as per the dosing regimen given on product insert approved in Philippines.
干预措施: No intervention (Drug)
结局指标
主要结局
Number of patients with incidence of adverse events
时间窗: Up to Week 24
Number of patients with incidence of discontinuation of study medication due to adverse events
时间窗: Up to Week 24
次要结局
- Number of patients who show complete remission(Week 4, Week 8, Week 12, Week 16, Week 20, Week 24)
- Number of patients with lack of effect (failure of expected pharmacologic action)(Week 4, Week 8, Week 12, Week 16, Week 20, Week 24)
- Number of patients who show partial remission(Week 4, Week 8, Week 12, Week 16, Week 20, Week 24)
- Number of patients with stable disease(Week 4, Week 8, Week 12, Week 16, Week 20, Week 24)
- Number of patients who show disease progression(Week 4, Week 8, Week 12, Week 16, Week 20, Week 24)