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Status:

COMPLETED

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

Lead Sponsor:

Cephalon

Conditions:

Non-Hodgkin's Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 a...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    October 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2009

    Estimated Enrollment :

    103 Patients enrolled

    Trial Details

    Trial ID

    NCT00139841

    Start Date

    October 1 2005

    End Date

    October 1 2009

    Last Update

    May 9 2014

    Active Locations (40)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 10 (40 locations)

    1

    University of Alabama Birmingham

    Birmingham, Alabama, United States, 35233

    2

    Arizona Cancer Center

    Tucson, Arizona, United States, 85724

    3

    Alta Bates Comprehensive Cancer Center

    Berkeley, California, United States, 94704

    4

    Tower Hematology and Oncology Medical Group

    Beverly Hills, California, United States, 90211