Clinical trial NCT01500083: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Indolent Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Keywords: iNHL
CLL
Lead sponsor: Lundbeck Canada Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: Up to 266 days
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: CA015
state: Alberta
city: Edmonton
country: Canada
facility: CA014
state: Alberta
city: Kelowna
country: Canada
facility: CA016
state: British Columbia
city: Vancouver
country: Canada
facility: CA011
state: British Columbia
city: Victoria
country: Canada
facility: CA013
state: British Columbia
city: Winnipeg
country: Canada
facility: CA012
state: Manitoba
city: Halifax
country: Canada
facility: CA004
state: Nova Scotia
city: Brampton
country: Canada
facility: CA009
state: Ontario
city: Hamilton
country: Canada
facility: CA003
state: Ontario
city: Ottawa
country: Canada
facility: CA002
state: Ontario
city: Toronto
country: Canada
facility: CA006
state: Ontario
city: Windsor
country: Canada
facility: CA005
state: Ontario
city: Montreal
country: Canada
facility: CA001
state: Quebec
city: Montreal
country: Canada
facility: CA010
state: Quebec
city: Saskatoon
country: Canada
facility: CA007
state: Saskatchewan
city: Quebec
country: Canada
facility: CA008
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: