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

November 30, 2015 updated by: Janssen Pharmaceutica

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bendamustine hydrochloride
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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who show complete remission
Time Frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
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
Time Frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
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
Time Frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
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
Time Frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
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)
Time Frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Pharmaceutica

Investigators

  • Study Director: Jannsen Pharmaceutica Clinical trial, Jannsen Pharmaceutica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

November 29, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 3, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100917
  • BENDAMUSCLL4001 (Other Identifier: Jannsen Pharmaceutica)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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