Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
Lymphoma, Non-Hodgkin, MALT Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Fludarabine, Rituximab, Marginal Zone Lymphoma, MALT lymphoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed, newly diagnosed or relapsed MALT, marginal zone lymphoma, or low-grade B cell lymphoproliferative disorder which is CD5-, CD10- and CD20+ Pathology must be reviewed at Brigham & Women's Hospital, Massachusetts General Hospital, or the University of Rochester James P. Wilmot Cancer Center prior to enrollment Documentation of CD20+ status Must not be a candidate for local radiotherapy with curative intent If gastric MALT, not a candidate for antibiotic therapy with curative intent Patients with leukemic phase marginal zone lymphoma are eligible if their absolute lymphocyte count is >10,000 / µl Prior treatment with rituximab is permitted, if rituximab induced an objective response which persisted for at least 6 months Prior radiotherapy is acceptable Measurable disease ANC: > 1000/mm3 Platelets: > 100,000/mm3 Hemoglobin: > 7 gm/dL Adequate renal function as indicated by serum creatinine <= 2 mg/dL. Adequate liver function, as indicated by serum total bilirubin <= 2 mg/dL. AST or ALT <3x Upper Limit of Normal unless related to primary disease. Men and women of reproductive potential must agree to use an acceptable method of birth control during study treatment and for six months after completion of study treatment. WHO Performance status </= 2 Subject has provided written informed consent. Exclusion Criteria: Patients with Waldenstrom's Macroglobulinemia or lymphoplasmacytic lymphoma are excluded History of HIV Active infection Known CNS disease Pregnant (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or currently lactating women Prior treatment within the last three weeks Prior fludarabine Positive direct antiglobulin test
Sites / Locations
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- University of Rochester Cancer Center
Arms of the Study
Arm 1
Experimental
Fludarabine and Rituximab
Fludarabine: 25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles Rituximab: 375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.