Bendamustine Hydrochloride (HCl) in Indolent Non-Hodgkin's Lymphoma That Has Progressed During or Following Treatment With a Rituximab Regimen or Previously Untreated Chronic Lymphocytic Leukemia (BENDACT)

June 29, 2017 updated by: Lundbeck Canada Inc.

An Open-Label Expanded Access Trial for Bendamustine HCl in Patients With Indolent Non-Hodgkin's Lymphoma That Has Progressed During or Following Treatment With a Rituximab Regimen or Previously Untreated Chronic Lymphocytic Leukemia

The purpose of the current study is to evaluate additional safety data of bendamustine in up to 100 patients with Indolent Non-Hodgkin's Lymphoma (iNHL) relapsing from a rituximab regimen or Chronic Lymphocytic Leukemia (CLL). Patients will receive up to 6 or 8 cycles of bendamustine treatment using the dosing regimens of TREANDA® (bendamustine) approved in several countries, which have been shown to be reasonably well tolerated. The study protocol includes safety monitoring (i.e., adverse events, concomitant medications, supportive care, clinical safety laboratory tests, and clinical disease status monitoring).

It is an interventional, multicentre, prospective, open-label expanded access study, which in addition allows investigators in Canada, and their patients, access to bendamustine while it is pending Canadian marketing approval.

Although the treatment options available for patients with iNHL or CLL do induce substantial responses, there is no curative treatment. One potential drug candidate for the treatment of CLL and iNHL is bendamustine.

Bendamustine has been widely used in Germany for more than 30 years and is marketed in the United States for treatment of CLL and for treatment of iNHL that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. In October 2010, the European Medicines Agency formally approved bendamustine in a number of Member States of the European Union for the treatment of patients with iNHL, CLL, and multiple myeloma. The drug's safety profile in these patient populations has been extensively characterized and no unexpected safety concerns are anticipated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1J 1Z4
        • CA008
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • CA015
      • Edmonton, Alberta, Canada, T6G 1Z2
        • CA014
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • CA016
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • CA011
      • Victoria, British Columbia, Canada, V8R 6V5
        • CA013
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CA012
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • CA004
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • CA009
      • Hamilton, Ontario, Canada, L8V 5C2
        • CA003
      • Ottawa, Ontario, Canada, K1H 8L6
        • CA002
      • Toronto, Ontario, Canada, M5G 2M9
        • CA006
      • Windsor, Ontario, Canada, N8W 2X3
        • CA005
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • CA001
      • Montreal, Quebec, Canada, H4J 1C5
        • CA010
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • CA007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria for iNHL:

  • The patient has biopsy-confirmed diagnosis of indolent B-cell NHL documented as relapsed or refractory iNHL (following rituximab-based therapy).

  • The patient has one of the following types of indolent B-cell lymphoma:

    • follicular lymphoma grade 1, 2, or 3A
    • marginal zone lymphoma
    • lymphoplasmacytic lymphoma
    • small lymphocytic lymphoma
  • The patient has adequate haematologic function (unless abnormalities are related to lymphoma involvement of the bone marrow or hypersplenism caused by lymphoma).

Inclusion Criteria for CLL:

  • The patient has previously confirmed (according to WHO criteria) untreated symptomatic chronic B-cell lymphocytic leukemia Binet Stage B or Binet Stage C or Rai stage II to IV in need of medical treatment.
  • The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria:

  • The patient has participated in a clinical study <30 days prior to the Screening Visit.

  • The patient has one or more of the following conditions:

    • active transformed lymphoma
    • any history of central nervous system or leptomeningeal lymphoma
    • an active malignancy other than the target cancer within the past 5 years
    • human immunodeficiency virus
  • The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with Chronic Lymphocytic Leukemia (CLL)
Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles.
Drug: Bendamustine at a dose of 100 mg/m2
Bendamustine will be administered intravenously over 30 minutes.
Other Names:
  • Treanda®
EXPERIMENTAL: Patients with Indolent Non-Hodgkin's Lymphoma (iNHL)
Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles.
Drug: Bendamustine at a dose of 120 mg/m2
Bendamustine will be administered intravenous (i.v.) over 60 minutes.
Other Names:
  • Treanda®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Adverse Events
Time Frame: Up to 266 days
Up to 266 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lundbeck Canada Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

December 16, 2011

First Submitted That Met QC Criteria

December 23, 2011

First Posted (ESTIMATE)

December 26, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14293A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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