SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

Completed · Phase 2

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT00076349

Run by

Cephalon

People needed

66

Starts

2004-04-01

Expected to finish

2008-03-01

Last updated by the study team

2014-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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 D.C., 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

Full record on ClinicalTrials.gov

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