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

Lead Sponsor

Lundbeck Canada Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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).
•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.

•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.

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