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

Janssen (J&J Innovative Medicine)

Status: Withdrawn

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01739491

CR100917

BENDAMUSCLL4001 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Bendamustine hydrochloride

Description:

Adult Filipino patients with chronic lymphocytic leukemia will be taking bendamustine hydrochloride as per the dosing regimen given on product insert approved in Philippines.

Treatment:

Drug: No intervention