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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of patients with incidence of adverse events

Outcome Time Frame:

Up to Week 24

Safety Issue:

Yes

Principal Investigator

Jannsen Pharmaceutica Clinical trial

Investigator Role:

Study Director

Investigator Affiliation:

Jannsen Pharmaceutica

Authority:

Philippines : Food and Drug Administration

Study ID:

CR100917

NCT ID:

NCT01739491

Start Date:

October 2014

Completion Date:

November 2016

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Chronic lymphocytic leukemia
  • Bendamustine hydrochloride
  • Leukemia
  • Filipino
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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