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
N/A
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma
Both
Non-Hodgkin's Lymphoma
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
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)
Type of Study:
Interventional
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:
No
Authority:
United States: Food and Drug Administration
Study ID:
SDX-105-03
NCT ID:
NCT00139841
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
Name | Location |
|---|---|
| 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 |
