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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

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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
Links
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.




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