A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia

Janssen Pharmaceutica

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Chronic Lymphocytic Leukemia

Interventions

No interventionDRUG

This is an obeservational study. Bendamustine hydrochloride will be administered (as per product insert) through intravenous infusion over 30-60 minutes at 100 mg/meter square body surface area on days 1 and 2 of a 28-day cycle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of patients with incidence of adverse events

Time frame: Up to Week 24

Number of patients with incidence of discontinuation of study medication due to adverse events

Time frame: Up to Week 24

Secondary Outcomes

Number of patients who show complete remission

Number of patients with complete remission will be evaluated using the National Cancer Institute-Sponsored Working Group (NCISWG) criteria.