The study is cancelled. FDA Circular 2013-004 mandates that PMSs like this are not required

The purpose of this study is to assess safety and effectiveness of extended bendamustine in the treatment of chronic lymphocytic leukemia (CLL).

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

The study population will include adult Filipino patients who are diagnosed with chronic lymphocytic leukemia.