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

NCT ID: NCT01739491

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jannsen Pharmaceutica Clinical trial

Role: STUDY_DIRECTOR

Jannsen Pharmaceutica

Other Identifiers

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BENDAMUSCLL4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR100917

Identifier Type: -

Identifier Source: org_study_id