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
Condition: Indolent Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Bendamustine at a dose of 100 mg/m2; Bendamustine at a dose of 120 mg/m2
Intervention description: Bendamustine will be administered intravenously over 30 minutes.; Bendamustine will be administered intravenous (i.v.) over 60 minutes.
Intervention MeSH terms: Bendamustine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: iNHL; CLL

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.