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Trial record 49 of 314 for:    BENDAMUSTINE

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01500083
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : October 16, 2014
Last Update Posted : August 14, 2017
Information provided by (Responsible Party):
Lundbeck Canada Inc.

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Indolent Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Drug: Bendamustine at a dose of 100 mg/m2 Drug: Bendamustine at a dose of 120 mg/m2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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 Name: 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 Name: Treanda®

Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: Up to 266 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01500083

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Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 5L3
Vancouver, British Columbia, Canada, V5Z 4E6
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Brampton, Ontario, Canada, L6R 3J7
Hamilton, Ontario, Canada, L8V 5C2
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 2M9
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Montreal, Quebec, Canada, H2W 1S6
Montreal, Quebec, Canada, H4J 1C5
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Lundbeck Canada Inc.
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Study Director: Email contact via H. Lundbeck A/S

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Responsible Party: Lundbeck Canada Inc. Identifier: NCT01500083     History of Changes
Other Study ID Numbers: 14293A
First Posted: December 26, 2011    Key Record Dates
Results First Posted: October 16, 2014
Last Update Posted: August 14, 2017
Last Verified: June 2017
Keywords provided by Lundbeck Canada Inc.:
Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action