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Primary Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab

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Trial Information

Primary Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab

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.

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).

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:


Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Study goal is to see how well the drugs 2CdA, cyclophosphamide, and rituximab (rituxan) shrink a lymphoma called Waldenstrom's macroglobulinemia.

Outcome Time Frame:

10 Years

Safety Issue:


Principal Investigator

Donna M. Weber, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 1999

Completion Date:

Related Keywords:

  • Lymphoma
  • Waldenstrom's Macroglobulinemia
  • Lymphoma
  • 2CdA
  • Cladribine
  • Leustatin
  • Cyclophosphamide
  • Cytoxan
  • Neosar
  • Rituxan
  • Rituximab
  • Lymphoma



UT MD Anderson Cancer Center Houston, Texas  77030