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

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

Detailed Description
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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.

Official Title
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A Post-Marketing Surveillance Study on the Safety And Effectiveness of Bendamustine Hydrochloride Among Adult Filipino Patients With Chronic Lymphocytic Leukemia

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bendamustine hydrochloride<br>Adult Filipino patients with chronic lymphocytic leukemia will be taking bendamustine hydrochloride as per the dosing regimen given on product insert approved in Philippines. | Drug: No intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with incidence of adverse events |  | Up to Week 24 | 
| Number of patients with incidence of discontinuation of study medication due to adverse events |  | Up to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | 
| Number of patients who show partial remission | Number of patients with partial remission will be evaluated using the National Cancer Institute-Sponsored Working Group (NCISWG) criteria. | Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | 
| Number of patients with stable disease | Number of patients with stable disease will be evaluated using the National Cancer Institute-Sponsored Working Group (NCISWG) criteria. | Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | 
| Number of patients who show disease progression | Number of patients with disease progression will be evaluated using the National Cancer Institute-Sponsored Working Group (NCISWG) criteria. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic lymphocytic leukemia, Bendamustine hydrochloride, Leukemia, Filipino