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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00139841
First Posted: August 31, 2005
Last Update Posted: May 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
August 18, 2005
August 31, 2005
May 9, 2014
October 2005
July 2007   (Final data collection date for 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 ]
Not Provided
Complete list of historical versions of study NCT00139841 on ClinicalTrials.gov Archive Site
• 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 ]
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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
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
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
Drug: Bendamustine HCl
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.
Experimental: 1
bendamustine
Intervention: Drug: Bendamustine HCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
October 2009
July 2007   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Puerto Rico,   United States
 
 
NCT00139841
SDX-105-03
Not Provided
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Teva Pharmaceutical Industries ( Cephalon )
Cephalon
Not Provided
Not Provided
Teva Pharmaceutical Industries
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP