SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
NCT ID: NCT00076349
Last Updated: 2014-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2004-04-30
2008-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
open-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab
bendamustine and rituximab
Patients will receive rituximab on the first day of a cycle at a dose of 375 mg/m2, followed on the second and third day of a cycle by SDX-105 (bendamustine) at a dose of 90 mg/m2/day of treatment. Four cycles are planned. Patients will receive a dose of rituximab alone 7 days prior to the first cycle of the combination and a dose of rituximab 28 days after the last cycle of the combination. If there is documented disease regression, a fifth and sixth cycle of SDX-105 plus rituximab may be administered.
Interventions
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bendamustine and rituximab
Patients will receive rituximab on the first day of a cycle at a dose of 375 mg/m2, followed on the second and third day of a cycle by SDX-105 (bendamustine) at a dose of 90 mg/m2/day of treatment. Four cycles are planned. Patients will receive a dose of rituximab alone 7 days prior to the first cycle of the combination and a dose of rituximab 28 days after the last cycle of the combination. If there is documented disease regression, a fifth and sixth cycle of SDX-105 plus rituximab may be administered.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Responsible Party
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Locations
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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
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
North Eastern Ontario Regional Cancer Center
Greater Sudbury, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Hopital Notre-Dame Du Chum
Montreal, Quebec, Canada
Countries
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Other Identifiers
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SDX-105-02
Identifier Type: -
Identifier Source: org_study_id
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