Clinical trial NCT01739491: A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia
Official title: A Post-Marketing Surveillance Study on the Safety And Effectiveness of Bendamustine Hydrochloride Among Adult Filipino Patients With Chronic Lymphocytic Leukemia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic lymphocytic leukemia
Bendamustine hydrochloride
Leukemia
Filipino
Lead sponsor: Janssen Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2012-12-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult Filipino patients who are diagnosed with chronic lymphocytic leukemia.

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with incidence of adverse events
timeFrame: Up to Week 24
measure: Number of patients with incidence of discontinuation of study medication due to adverse events
timeFrame: Up to Week 24
Secondary outcomes:
measure: Number of patients who show complete remission
timeFrame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Number of patients who show partial remission
timeFrame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Number of patients with stable disease
timeFrame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Number of patients who show disease progression
timeFrame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Number of patients with lack of effect (failure of expected pharmacologic action)
timeFrame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Jannsen Pharmaceutica
name: Jannsen Pharmaceutica Clinical trial
role: STUDY_DIRECTOR
References: