Status:
COMPLETED
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.
Conditions:
Indolent Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 L...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01500083
Start Date
March 1 2012
End Date
June 1 2013
Last Update
August 14 2017
Active Locations (16)
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1
CA015
Calgary, Alberta, Canada, T2N 4N2
2
CA014
Edmonton, Alberta, Canada, T6G 1Z2
3
CA016
Kelowna, British Columbia, Canada, V1Y 5L3
4
CA011
Vancouver, British Columbia, Canada, V5Z 4E6