Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin’s Lymphoma

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 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