Status:
COMPLETED
SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Cephalon
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00076349
Start Date
April 1 2004
End Date
March 1 2008
Last Update
May 9 2014
Active Locations (34)
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1
Alaska Cancer Research and Education Center
Anchorage, Alaska, United States, 99508
2
Bay Area Cancer Research Group
Concord, California, United States, 94520
3
Wilshire Oncology Medical Group
La Verne, California, United States, 91750
4
USC/Kenneth Norris Jr. Cancer Hospital and Research Institute
Los Angeles, California, United States, 90033