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

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

This study is ongoing, but not recruiting participants.
Information provided by Cephalon

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
Official Title ^†	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
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†	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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measure ^†	• 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Condition ^†	Non-Hodgkin's Lymphoma
Intervention ^†	Drug: Bendamustine HCl
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	103
Start Date ^†	October 2005
Completion Date	August 2009
Eligibility Criteria ^†	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Canada, Puerto Rico

Administrative Information Fields
NCT ID ^†	NCT00139841
Organization ID	SDX-105-03
Secondary IDs ^††
Study Sponsor ^†	Cephalon
Collaborators ^††
Investigators ^†
Information Provided By	Cephalon
Verification Date	June 2008
First Received Date ^†	August 18, 2005
Last Updated Date	June 24, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.