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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

Phase 3
18 Years
Not Enrolling
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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

Inclusion Criteria


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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

6 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

October 2009

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma, Non-Hodgkin
  • Rituximab Refractory
  • Rituximab Failure
  • Indolent Non-Hodgkins Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Arizona Cancer Center Tucson, Arizona  85724
Roswell Park Cancer Institute Buffalo, New York  14263
University of Colorado Cancer Center Denver, Colorado  80262
Rush University Medical Center Chicago, Illinois  60612-3824
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
Arlington Cancer Center Arlington, Texas  76012
University of Virginia Cancer Center Charlottesville, Virginia  22908
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
Moores UCSD Cancer Center La Jolla, California  92093-0658
Henry Ford Health System Detroit, Michigan  48202
University of Michigan Cancer Center Ann Arbor, Michigan  48109
Dana Farber Cancer Institute Boston, Massachusetts  02115
Georgetown University Medical Center Washington, District of Columbia  20007
University of Rochester Medical Center, James P. Wilmot Cancer Center Rochester, New York  14642
Yale University School Of Medicine New Haven, Connecticut  06520
University of Wisconsin Madison,, Wisconsin  53792-5666
Nevada Cancer Institute Las Vegas, Nevada  89135
Sarah Cannon Research Institute Nashville, Tennessee  37203
University of Alabama Birmingham Birmingham, Alabama  35233
Tower Hematology and Oncology Medical Group Beverly Hills, California  90211
USC/Norris Cancer Hospital Los Angeles, California  90033
Comprehensive Cancer Center - Desert Regional Medical Center Palm Springs, California  92662
Stanford University Division of Oncology Stanford, California  94305
Indiana Oncology Hematology Consultants, A Division of AHN Indianapolis, Indiana  46202
Markey Cancer Center, University of Kentucky Medical Center Lexington, Kentucky  40536
LSU Health Sciences Center, Feist Weiller Cancer Center Shreveport, Louisiana  71130
Washington University School of Medicine in St. Louis St. Louis, Missouri  63110
Weill Cornell Cancer Care Center New York, New York  10021
Interlakes Foundation, Inc. Rochester, New York  14623
Duke University School of Medicine Durham, North Carolina  27710
The Cleveland Clinic Foundation Taussig Cancer Center Cleveland, Ohio  44195
The West Clinic/ACORN Memphis, Tennessee  38138