Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab
Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab
The goal of this clinical research study is to see how well the drugs 2CdA, cyclophosphamide,
 and rituximab (rituxan) shrink a lymphoma called Waldenstrom's macroglobulinemia. After these
 drugs are given for 2 courses, a second goal is to see how long a remission lasts. A third
 goal is to see how often repeat remissions can be achieved when the lymphoma returns later
 and the same drugs are restarted.

 This is an investigational study. The FDA has approved each of these drugs for the treatment
 of low-grade lymphoma. The combined use of these drugs for Waldenstrom's macroglobulinemia is
 investigational, although each drug has been effective by itself for this disease. About 50
 patients will take part in this study. This study will take place only at UTMDACC (outpatient
 basis).
Before the study starts, patients will have a complete exam. Blood and urine tests will be
 done. A bone marrow test, a chest x-ray and a CT scan of the abdomen will be done if not
 studied recently.

 Blood tests will be repeated after 14, 21, and 42 days. Provided the disease has responded,
 another bone marrow sample will be taken to confirm remission. X-rays may be repeated for the
 same reason.

 The patient or a family member will be taught to inject 2CdA under the skin three times a day
 for 7 days. The patient will also take cyclophosphamide by mouth twice each day. Rituxan will
 be given by vein once weekly for 4 weeks after a test infusion on the day prior to the first
 injection. A second course of the 3 drugs will be given about 6 weeks after the start of the
 first course. All patients with improving disease will then be followed without further
 treatment.
Inclusion Criteria:

 1. Newly diagnosed patients with symptomatic macroglobulinemic lymphoma are eligible.
 Macroglobulinemic lymphoma includes patients with either biopsy proven small
 lymphocytic lymphoma or chronic lymphocytic leukemia and monoclonal IgM. Also included
 are symptomatic patients with clonal proliferation producing a pathologic monoclonal
 IgM that causes cryoglobulinemia, peripheral neuropathy or cold agglutinin hemolytic
 anemia.

 2. Patients must have adequate liver function (bilirubin <2.5 mg%) and renal function
 (creatinine <2.0 mg%).

 Exclusion Criteria:

 None.