Status:
COMPLETED
Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Conditions:
Lymphoma, Non-Hodgkin
MALT Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 lymp...
Detailed Description
Objectives: Primary \- To estimate the objective response rate. Secondary * To assess the safety. * To describe the progression-free survival at one year. * To examine the association between clon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00117156
Start Date
December 1 2003
End Date
January 1 2012
Last Update
August 1 2016
Active Locations (4)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
University of Rochester Cancer Center
Rochester, New York, United States, 14627