Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
Condition: Lymphoma, Non-Hodgkin; MALT Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone
Intervention: Fludarabine; Rituximab
Intervention MeSH terms: Rituximab; Fludarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fludarabine; Rituximab; Marginal Zone Lymphoma; MALT lymphoma

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.
    

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