The purpose of this study is to determine the effectiveness of six cycles of concurrent fludarabine and rituximab in patients with marginal zone or CD5-, CD10-, CD20+ low-grade B cell lymphomas.

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin MALT Lymphoma	Drug: Fludarabine  Drug: Rituximab	Phase II

Further Study Details: 

Primary Outcomes: Determine the objective response rate following six cycles of fludarabine and rituximab in this population
Secondary Outcomes: Assess the safety; describe the progression-free survival at one year; examine the association between cytogenetic abnormalities identified by FISH and the objective response rate
Expected Total Enrollment:  30

The purposes of this study are:

• To estimate the objective response rate (CR, CRu, PR) to six cycles of concurrent fludarabine and rituximab in patients with disseminated or recurrent CD5-, CD10-, CD20+ low-grade B cell lymphomas.
• To assess the safety of fludarabine and rituximab in this patient population.
• To describe the progression-free survival at one year.
• To examine the association between clonal cytogenetic abnormalities identified by FISH, and the objective response rate as well as the progression-free survival at one year.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00117156

Jennifer R. Brown, MD, PhD      617-632-6692    jennifer_brown@dfci.harvard.edu
Kimberly S. Phillips      617-582-7970    kimberly_phillips@dfci.harvard.edu

Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02115,  United States; Recruiting
New York
      University of Rochester Cancer Center, Rochester,  New York,  14627,  United States; Recruiting

Study chairs or principal investigators

Jennifer R. Brown, MD, PhD,  Principal Investigator,  Dana-Farber Cancer Institute   

Study ID Numbers:  03-294
Record last reviewed:  June 2005
Last Updated:  July 1, 2005
Record first received:  July 1, 2005
ClinicalTrials.gov Identifier:  NCT00117156
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-05