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
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
- The patient has participated in a clinical study <30 days prior to the Screening
- 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.