Phase II Pilot Study Of Rituximab Plus CHOP In Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia

Inclusion Criteria

INCLUSION CRITERIA:

- Diagnosis of Waldenstrom's macroglobulinemia confirmed by the presence of the
following:

- Bone marrow lymphoplasmacytosis with: > 10% lymphoplasmacytic cells OR
aggregates or sheets of one of the following: lymphocytes, plasma cells or
lymphoplasmacytic cells on the bone marrow biopsy (measured within 4 weeks prior
to registration)

- Measurable disease defined as a quantitative immunoglobulin M (IgM) monoclonal
protein of > 1,000 mg/dL obtained within 4 weeks prior to registration

- Cluster of differentiation 20 (CD20) positive stain of bone marrow or lymph node
samples obtained < 8 weeks prior to registration

- Impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma,
defined by 1 of the following:

- Hemoglobin no greater than 11 g/dL

- Serum viscosity level relative to water of at least 4.0 centipoise

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 75,000/mm^3

- Bilirubin no greater than 3.0 mg/dL

- Aspartate aminotransferase (AST) no greater than 3 times upper limit of normal

- Creatinine no greater than 3.0 mg/dL

- Age of 18 and over

- ECOG (Eastern Cooperative Oncology Group) performance status 0-1

- Must be symptomatic with 1 of the following:

- Clinically significant anemia (hemoglobin no greater than 11 g/dL)

- Bulky lymphadenopathy

- Symptoms attributable to hyperviscosity (e.g., nose bleeding, gingival bleeding,
or retinal hemorrhage)

- History of heart disease allowed only if 1 of the following is demonstrated by
echocardiography, multigated acquisition scan (MUGA), exercise MUGA, or coronary
catheterization:

- Ejection fraction of at least 45%

- Normal fractional shortening of the left ventricle

- Must have been tested for hepatitis B surface antigen within 2 weeks of registration

- Negative pregnancy test

- Fertile patients must use effective contraception

EXCLUSION CRITERIA:

- Prior treatment for Waldenstrom's macroglobulinemia

- Prior anti-CD20 therapy

- Concurrent steroids exceeding 10 mg prednisone (or equivalent) per day

- Prior irradiation if less than 4 weeks had elapsed prior to registration and the date
of last treatment

- Prior anthracyclines

- Prior malignancy except curatively treated basal cell or squamous cell carcinoma of
the skin, carcinoma in situ of the cervix, or other cancer curatively treated with
surgery alone and from which patient has been disease free for at least 5 years

- Active heart disease

- Pregnant or nursing

- Myocardial infarction within the past 3 months

- Congestive heart failure

- Symptomatic ventricular arrhythmia