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 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.
Indolent Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
|Study Design:||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|
- Number of adverse events in patients in Canada with iNHL that has progressed during or following treatment with a rituximab regimen [ Time Frame: Up to 266 days ] [ Designated as safety issue: Yes ]
- Number of adverse events in patients in Canada with previously untreated CLL [ Time Frame: Up to 266 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2012|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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. Bendamustine will be administered intravenous (i.v.) over 60 minutes. Dosing can be reduced as needed.
Other Name: Treanda®Drug: Bendamustine
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. Bendamustine will be administered i.v. over 30 minutes. Dosing can be reduced as needed.
Other Name: Treanda®
|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|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|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|
|Montreal, Quebec, Canada, H2W 1S6|
|Montreal, Quebec, Canada, H4J 1C5|
|Saskatoon, Saskatchewan, Canada, S7N 4H4|
|Quebec, Canada, G1J 1Z4|
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|