Rituximab for Waldenstrom's Macroglobulinemia (WM): A Phase II Pilot Study for Untreated or Previously Treated Patients

Inclusion Criteria

DISEASE CHARACTERISTICS: Waldenstrom's macroglobulinemia confirmed by the following: Bone
marrow lymphoplasmacytosis with: Greater than 10% lymphoplasmacytic cells OR Aggregates,
sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy AND
Measurable disease defined as quantitative IgM monoclonal protein greater than 1,000 mg/dL
Bone marrow lymphoplasmacytosis and beta-2 microglobulin in the serum are not considered
measurable Impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma
Hemoglobin less than 11 g/dL OR Serum viscosity level relative to water greater than 4.0
Symptomatic with clinically significant anemia (less than 11 g/dL), bulky lymphadenopathy
that is symptomatic, or symptoms attributable to hyperviscosity (e.g., nose bleeding,
gingival bleeding, retinal hemorrhage)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy:
Not specified Hematopoietic: See Disease Characteristics Hepatic: SGOT less than 3 times
upper limit of normal Bilirubin less than 2.0 mg/dL Renal: Creatinine no greater than 3.0
mg/dL Cardiovascular: No myocardial infarction within past 6 months No significant
arrhythmia within past 3 months Hypertension allowed provided controlled with medication
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception Concurrent reversible complications (e.g., hyperuricemia, hyperviscosity)
allowed provided therapy for complication initiated and complications subsiding Other
prior malignancies allowed provided curatively treated and currently disease free

PRIOR CONCURRENT THERAPY: No more than 2 prior regimens allowed Prior tandem transplant
considered 2 prior regimens Chemotherapy prior to bone marrow transplantation as part of
induction considered 1 prior regimen Retreatment with same regimen (e.g., repeated
alkylating agents) considered 1 prior regimen Biologic therapy: No prior anti-CD20 therapy
At least 1 month since prior epoetin alfa No concurrent epoetin alfa for 2 months after
registration Chemotherapy: At least 28 days since prior alkylating agents At least 28 days
since prior purine nucleoside analogues Endocrine therapy: At least 28 days since prior
corticosteroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy Surgery:
Not specified Other: Concurrent digoxin to control atrial fibrillation allowed