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

Completed · Phase 2

Conditions studied: Lymphoma, Non-Hodgkin, MALT Lymphoma

In brief

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.

Key facts

Study ID

NCT00117156

Run by

Dana-Farber Cancer Institute

People needed

26

Starts

2003-12-01

Expected to finish

2012-01-01

Last updated by the study team

2016-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Rochester Cancer Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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