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

Chronic Lymphocytic Leukemia Clinical Trial

— BENDACT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500083
• Other study ID #: 14293A
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2011
• Last updated: October 16, 2014
• Start date: March 2012

Study information

• Verified date: October 2014
• Source: Lundbeck Canada Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Indolent Non-Hodgkin's Lymphoma
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Bendamustine at a dose of 100 mg/m2
Bendamustine will be administered intravenously over 30 minutes.
• Bendamustine at a dose of 120 mg/m2
Bendamustine will be administered intravenous (i.v.) over 60 minutes.

Locations

Country	Name	City	State
Canada	CA009	Brampton	Ontario
Canada	CA015	Calgary	Alberta
Canada	CA014	Edmonton	Alberta
Canada	CA004	Halifax	Nova Scotia
Canada	CA003	Hamilton	Ontario
Canada	CA016	Kelowna	British Columbia
Canada	CA001	Montreal	Quebec
Canada	CA010	Montreal	Quebec
Canada	CA002	Ottawa	Ontario
Canada	CA008	Quebec
Canada	CA007	Saskatoon	Saskatchewan
Canada	CA006	Toronto	Ontario
Canada	CA011	Vancouver	British Columbia
Canada	CA013	Victoria	British Columbia
Canada	CA005	Windsor	Ontario
Canada	CA012	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Lundbeck Canada Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		Up to 266 days	Yes