Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
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.
Interventional
Primary Purpose: Treatment
Christos E. Emmanouilides, MD
Principal Investigator
Jonsson Comprehensive Cancer Center
United States: Federal Government
CDR0000068714
NCT00020800
September 2001
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Cedars-Sinai Medical Center | Los Angeles, California 90048 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
| Tuft-New England Medical Center | Boston, Massachusetts 02111 |
| Barrett Cancer Center | Cincinnati, Ohio 45267-0502 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |