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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness of six cycles of concurrent fludarabine and rituximab in patients with mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphoma (MZL) or CD5-, CD10-, CD20+ low-grade B cell lymphomas.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Biogen; Genentech, Inc.; Massachusetts General Hospital; University of Rochester
• Treatments: Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

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
• 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