Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia

Study Overview
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Brief Summary
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RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating patients who have Waldenstrom's macroglobulinemia.

Detailed Description
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OBJECTIVES: Determine the objective response and time to treatment failure in patients with Waldenstrom's macroglobulinemia treated with rituximab and fludarabine. Determine the toxicity of this regimen in these patients. Determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen. OUTLINE: This is a multicenter study. Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4, 17, 18, 30, and 31 and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5, 9, 13, 19, 23, and 27. Patients are followed at least every 2 months for 2 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Official Title
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Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: rituximab
* Drug: fludarabine phosphate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of Waldenstrom's macroglobulinemia CD20 positive by bone marrow immunohistochemistry or flow cytometry Presence of monoclonal paraprotein IgM level at least 2 times upper limit of normal (ULN) PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 25,000/mm^3 Hepatic: Bilirubin less than 2.5 times ULN SGOT less than 2.5 times ULN Renal: Creatinine less than 2.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study No serious comorbid disease No uncontrolled bacterial, fungal, or viral infection No other active malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: No prior rituximab No prior nucleoside analogue therapy Chemotherapy: At least 30 days since prior chemotherapy Endocrine therapy: At least 30 days since prior steroid therapy No concurrent corticosteroids Radiotherapy: At least 30 days since prior radiotherapy Surgery: Not specified Other: No more than 2 prior courses of therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: rituximab|nan|
|Drug: fludarabine phosphate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Waldenström macroglobulinemia