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A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma

Phase 2
18 Years
Not Enrolling
Lymphoma, Non-Hodgkin, MALT Lymphoma

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Trial Information

A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma

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.

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

- 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 / ┬Ál

- 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

- WHO Performance status
- Subject has provided written informed consent.

Exclusion Criteria:

- Patients with Waldenstrom's Macroglobulinemia or lymphoplasmacytic lymphoma are

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the objective response rate following six cycles of fludarabine and rituximab in this population

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jennifer R. Brown, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

December 2003

Completion Date:

January 2013

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • MALT Lymphoma
  • Fludarabine
  • Rituximab
  • Marginal Zone Lymphoma
  • MALT lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell, Marginal Zone



University of Rochester Cancer Center Rochester, New York  14642
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617