Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

Study Overview
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Brief Summary
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SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.

Official Title
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A Multi-Center Phase III Study to Investigate the Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

Conditions
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Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Bendamustine HCl


Participation Criteria
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Eligibility Criteria
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ELIGIBILITY: Key Inclusion Criteria Documented B-cell Non-Hodgkin's Lymphoma Small lymphocytic lymphoma (ALC < 5,000 cells/mm3) Marginal zone B-cell lymphoma (nodal, extranodal, or splenic types) Lymphoplasmacytic lymphoma Follicular center lymphoma, follicular Disease documented to be refractory to a full-course of the most recent rituximab therapy (single agent or combination) At least 1 prior chemotherapy regimen and maximum of 3 prior chemotherapy regimens Bidimensionally measurable disease (by CT scan) with at least one lesion measuring ≥ 2.0 cm in a single dimension Key Exclusion Criteria Patients who receive rituximab only as part of treatment with ibritumomab tiuxetan (Zevalin®) will not be eligible History of prior high dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible)

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>bendamustine | Drug: Bendamustine HCl<br>* Dose of 120 mg/m2 on Day 1 and Day 2 of each treatment cycle (every 21 days). Patients who are continuing to experience clinical benefit at Cycle 6, as assessed by the investigator, may receive up to 2 additional cycles, to a maximum of 8 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the overall response rate (ORR = CR + CRu + PR) and duration of response (DR) to a regimen of bendamustine in patients who are refractory to rituximab therapy. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • assess the safety profile of Treanda in this patient population. • assess the duration of progression-free survival (PFS). • estimate the basic pharmacokinetic parameters • assess the effects of plasma concentrations |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Non-Hodgkin, Rituximab Refractory, Rituximab Failure, Indolent Non-Hodgkins Lymphoma