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

Phase 3

Completed

• Conditions: Indolent Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia
• Interventions: Drug: Bendamustine at a dose of 120 mg/m2; Drug: Bendamustine at a dose of 100 mg/m2

• Registration Number: NCT01500083
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-23
• Study First Posted: 2011-12-26
• Study Start: 2012-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2014-10-10
• Results First Submitted QC: 2014-10-10
• Results First Posted: 2014-10-16
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-29
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Indolent Non-Hodgkin's Lymphoma (iNHL)	Bendamustine at a dose of 120 mg/m2	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.
Patients with Chronic Lymphocytic Leukemia (CLL)	Bendamustine at a dose of 100 mg/m2	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.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	Up to 266 days

Trial Locations

Locations (16)

CA016; 🇨🇦 Kelowna, British Columbia, Canada

CA014; 🇨🇦 Edmonton, Alberta, Canada

CA015; 🇨🇦 Calgary, Alberta, Canada

CA012; 🇨🇦 Winnipeg, Manitoba, Canada

CA011; 🇨🇦 Vancouver, British Columbia, Canada

CA013; 🇨🇦 Victoria, British Columbia, Canada

CA004; 🇨🇦 Halifax, Nova Scotia, Canada

CA009; 🇨🇦 Brampton, Ontario, Canada

CA003; 🇨🇦 Hamilton, Ontario, Canada

CA002; 🇨🇦 Ottawa, Ontario, Canada

CA006; 🇨🇦 Toronto, Ontario, Canada

CA005; 🇨🇦 Windsor, Ontario, Canada

CA001; 🇨🇦 Montreal, Quebec, Canada

CA010; 🇨🇦 Montreal, Quebec, Canada

CA007; 🇨🇦 Saskatoon, Saskatchewan, Canada

CA008; 🇨🇦 Quebec, Canada