Spots Global Cancer Trial Database for SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
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Trial Identification
Brief Title: SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
Official Title: 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)
Study ID: NCT00076349
Conditions
Interventions
Study Description
Brief Summary: SUMMARY: This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression. RATIONALE: Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients. PURPOSE: This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Cancer Research and Education Center, Anchorage, Alaska, United States
Bay Area Cancer Research Group, Concord, California, United States
Wilshire Oncology Medical Group, La Verne, California, United States
USC/Kenneth Norris Jr. Cancer Hospital and Research Institute, Los Angeles, California, United States
San Diego Cancer Center, Vista, California, United States
Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center, Stamford, Connecticut, United States
Georgetown University Medical Center - Lombardi Cancer Center, Washington, District of Columbia, United States
Pasco Hernando Oncology, New Port Richey, Florida, United States
John B. Amos Cancer Center, Columbus, Georgia, United States
Suburban Hematology & Oncology Associates, Lawrenceville, Georgia, United States
Georgia Oncology Partners Research and Education Foundation, Macon, Georgia, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Oncology and Hematology, Metairie, Louisiana, United States
LSU Health Sciences Center, Shreveport, Louisiana, United States
Beth Israel/Deaconess Medical Center, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Hubert H. Humphrey Cancer Center, Robbinsdale, Minnesota, United States
The Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Arena Oncology Associates, Great Neck, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/Hematology, Rochester, New York, United States
ACORN - West Cancer Center, Memphis, Tennessee, United States
Southwest Regional Cancer Center, Austin, Texas, United States
Baylor University Medical Center, Dallas, Texas, United States
Univ. of Virginia Health System-Cancer Center Clinical Trials Office, Charlottesville, Virginia, United States
Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia
Royal Melbourne Hospital, Parkville, Victoria, Australia
St. Vincent's Hospital, Darlinghurst, , Australia
Westmead Hospital, Westmead, , Australia
Queen Elizabeth II Health Sciences Centre-Victoria General Site, Halifax, Nova Scotia, Canada
The Royal Victoria Hospital Cancer Care Program Clinical Trials, Barrie, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
North Eastern Ontario Regional Cancer Center, Sudbury, ,, Ontario, Canada
Hopital Notre-Dame Du Chum, Montreal, Quebec, Canada
Contact Details
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