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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lundbeck Canada Inc.
ClinicalTrials.gov Identifier:
NCT01500083
First received: December 16, 2011
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lundbeck Canada Inc.:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: Up to 266 days ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: March 2012
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT01500083

Locations
Canada, Alberta
CA015
Calgary, Alberta, Canada, T2N 4N2
CA014
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
CA016
Kelowna, British Columbia, Canada, V1Y 5L3
CA011
Vancouver, British Columbia, Canada, V5Z 4E6
CA013
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
CA012
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
CA004
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
CA009
Brampton, Ontario, Canada, L6R 3J7
CA003
Hamilton, Ontario, Canada, L8V 5C2
CA002
Ottawa, Ontario, Canada, K1H 8L6
CA006
Toronto, Ontario, Canada, M5G 2M9
CA005
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
CA001
Montreal, Quebec, Canada, H2W 1S6
CA010
Montreal, Quebec, Canada, H4J 1C5
Canada, Saskatchewan
CA007
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
CA008
Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Lundbeck Canada Inc.
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: Lundbeck Canada Inc.
ClinicalTrials.gov Identifier: NCT01500083     History of Changes
Other Study ID Numbers: 14293A
Study First Received: December 16, 2011
Results First Received: October 10, 2014
Last Updated: October 16, 2014
Health Authority: Canada: Health Canada

Keywords provided by Lundbeck Canada Inc.:
iNHL
CLL

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

ClinicalTrials.gov processed this record on November 25, 2014