Study Stopped
The study is cancelled. FDA Circular 2013-004 mandates that PMSs like this are not required
A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia
A Post-Marketing Surveillance Study on the Safety And Effectiveness of Bendamustine Hydrochloride Among Adult Filipino Patients With Chronic Lymphocytic Leukemia
2 other identifiers
observational
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to assess safety and effectiveness of extended bendamustine in the treatment of chronic lymphocytic leukemia (CLL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2014
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2012
CompletedFirst Posted
Study publicly available on registry
December 3, 2012
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedDecember 2, 2015
November 1, 2015
2.1 years
November 29, 2012
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Number of patients who show complete remission
Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Number of patients who show partial remission
Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Number of patients with stable disease
Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Number of patients who show disease progression
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
Study Arms (1)
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.
Interventions
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 Criteria
The study population will include adult Filipino patients who are diagnosed with chronic lymphocytic leukemia.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jannsen Pharmaceutica Clinical trial
Jannsen Pharmaceutica
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2012
First Posted
December 3, 2012
Study Start
October 1, 2014
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
December 2, 2015
Record last verified: 2015-11