Spots Global Cancer Trial Database for Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia
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Trial Identification
Brief Title: Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia
Official Title: Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Study ID: NCT00020800
Conditions
Study Description
Brief Summary: RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating patients who have Waldenstrom's macroglobulinemia.
Detailed Description: OBJECTIVES: * Determine the objective response and time to treatment failure in patients with Waldenstrom's macroglobulinemia treated with rituximab and fludarabine. * Determine the toxicity of this regimen in these patients. * Determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen. OUTLINE: This is a multicenter study. Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4, 17, 18, 30, and 31 and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5, 9, 13, 19, 23, and 27. Patients are followed at least every 2 months for 2 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Cancer Center, Tucson, Arizona, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Tuft-New England Medical Center, Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Barrett Cancer Center, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
Chedoke-McMaster Hospitals, Hamilton, Ontario, Canada
Huddinge University Hospital, Stockholm, , Sweden
Saint Bartholomew's Hospital, London, England, United Kingdom
Contact Details
Name: Christos E. Emmanouilides, MD
Affiliation: Jonsson Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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