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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Indolent Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Bendamustine at a dose of 100 mg/m2
* Drug: Bendamustine at a dose of 120 mg/m2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Chronic Lymphocytic Leukemia (CLL)<br>Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. | Drug: Bendamustine at a dose of 100 mg/m2<br>* Bendamustine will be administered intravenously over 30 minutes.<br>* Other names: Treanda®;|
| Experimental: Patients with Indolent Non-Hodgkin's Lymphoma (iNHL)<br>Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. | Drug: Bendamustine at a dose of 120 mg/m2<br>* Bendamustine will be administered intravenous (i.v.) over 60 minutes.<br>* Other names: Treanda®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | Up to 266 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iNHL, CLL