A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Combination With Rituximab in Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
Phase 2
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 II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Combination With Rituximab in Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
Inclusion Criteria
INCLUSION CRITERIA:
Documented B-Cell NHL or mantle cell lymphoma
- CD-20+ tumor
- Indolent NHL: follicular B-cell lymphoma, diffuse small lymphoma, marginal zone
lymphoma
- Maximum of three prior chemotherapy regimens
- Age of at least 18 years at Screening Visit (Site specific requirement may differ)
EXCLUSION CRITERIA:
- Refractory to rituximab, defined as progression of disease while being treated with
rituximab or progression within 6 months of the last dose of rituximab (when given
either as a single agent or in combination)
- Previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6
weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to
any agents administered previously
- Use of investigational agents within 28 days of study
- History of prior high dose chemotherapy with allogeneic stem cell support
- History of prior radioimmunotherapy
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:
Determine the objective response rate (ORR = CR + PR) to a regimen of SDX-105 plus rituximab in patients with relapsed indolent or mantle cell non-Hodgkin's lymphoma
Outcome Time Frame:
4-6 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
SDX-105-02
NCT ID:
NCT00076349
Start Date:
April 2004
Completion Date:
March 2008
Related Keywords:
- Non-Hodgkin's Lymphoma
- Non-Hodgkin's Lymphoma
- NHL
- Rituxan
- Mantle Cell
- mabs
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Southwest Regional Cancer Center | Austin, Texas 78705 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
| Hubert H. Humphrey Cancer Center | Coon Rapids, Minnesota 55433 |
| Baylor University Medical Center | Dallas, Texas 75246 |
| John B. Amos Cancer Center | Columbus, Georgia 31904 |
| Arena Oncology Associates | Great Neck, New York 11021 |
| San Diego Cancer Center | Vista, California 92083 |
| Wilshire Oncology Medical Group | Glendora, California 91741 |
| Bay Area Cancer Research Group | Concord, California 94520 |
| The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| LSU Health Sciences Center | Shreveport, Louisiana 71130-3932 |
| Northern Indiana Cancer Research Consortium | South Bend, Indiana |
| Georgetown University Medical Center - Lombardi Cancer Center | Washington, District of Columbia 20007 |
| Alaska Cancer Research and Education Center | Anchorage, Alaska 99508 |
| USC/Kenneth Norris Jr. Cancer Hospital and Research Institute | Los Angeles, California 90033 |
| Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center | Stamford, Connecticut 06902-3628 |
| Pasco Hernando Oncology | New Port Richey, Florida 34652 |
| Suburban Hematology & Oncology Associates | Lawrenceville, Georgia 30045 |
| Georgia Oncology Partners Research and Education Foundation | Macon, Georgia 31201 |
| Oncology and Hematology | Metairie, Louisiana 70006-2921 |
| Beth Israel/Deaconess Medical Center | Boston, Massachusetts 02215 |
| Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/Hematology | Rochester, New York 14623 |
| ACORN - West Cancer Center | Memphis, Tennessee 38120 |
| Univ. of Virginia Health System-Cancer Center Clinical Trials Office | Charlottesville, Virginia 22908 |
