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

This study has been withdrawn prior to enrollment.
(Sponsor determined study is not required according to PFDA Circular 2013-004)
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01739491
First received: November 29, 2012
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-Marketing Surveillance Study on the Safety And Effectiveness of Bendamustine Hydrochloride Among Adult Filipino Patients With Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica:

Primary Outcome Measures:
  • Number of patients with incidence of adverse events [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
  • Number of patients with incidence of discontinuation of study medication due to adverse events [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients who show complete remission [ Time Frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 ] [ Designated as safety issue: No ]
    Number of patients with complete remission will be evaluated using the National Cancer Institute-Sponsored Working Group (NCISWG) criteria.

  • Number of patients who show partial remission [ Time Frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 ] [ Designated as safety issue: No ]
    Number of patients with partial remission will be evaluated using the National Cancer Institute-Sponsored Working Group (NCISWG) criteria.

  • Number of patients with stable disease [ Time Frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 ] [ Designated as safety issue: No ]
    Number of patients with stable disease will be evaluated using the National Cancer Institute-Sponsored Working Group (NCISWG) criteria.

  • Number of patients who show disease progression [ Time Frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 ] [ Designated as safety issue: No ]
    Number of patients with disease progression will be evaluated using the National Cancer Institute-Sponsored Working Group (NCISWG) criteria.

  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739491

Sponsors and Collaborators
Janssen Pharmaceutica
Investigators
Study Director: Jannsen Pharmaceutica Clinical trial Jannsen Pharmaceutica
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01739491     History of Changes
Other Study ID Numbers: CR100917, BENDAMUSCLL4001
Study First Received: November 29, 2012
Last Updated: August 9, 2013
Health Authority: Philippines : Food and Drug Administration

Keywords provided by Janssen Pharmaceutica:
Chronic lymphocytic leukemia
Bendamustine hydrochloride
Leukemia
Filipino

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Nitrogen Mustard Compounds
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014