Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia | NCT00060346 | Trialant

Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia | NCT00060346 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility 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