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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01739491
• Other study ID #: CR100917
• Secondary ID: BENDAMUSCLL4001
• Status: Withdrawn
• Phase: Phase 4
• First received: November 29, 2012
• Last updated: November 30, 2015
• Start date: October 2014
• Est. completion date: November 2016

Study information

• Verified date: November 2015
• Source: Janssen Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines : Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with incidence of adverse events		Up to Week 24	Yes
Primary	Number of patients with incidence of discontinuation of study medication due to adverse events		Up to Week 24	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of patients with lack of effect (failure of expected pharmacologic action)		Week 4, Week 8, Week 12, Week 16, Week 20, Week 24	No