Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments 2cda, cyclophosphamide, rituximab
Target CD20
Sponsor M.D. Anderson Cancer Center
Start date July 1999
End date July 2017
Trial size 50 participants
Trial identifier NCT00667329, DM99-070, NCI-2010-01457

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
2CdA 1.5 mg/m^2 subcutaneous injection three times daily x 7 days. Cyclophosphamide 40 mg/m^2 PO twice daily x 7 days. Rituximab 375 mg/m^2 IV once weekly x 4 weeks.
2cda Leustatin
1.5 mg/m^2 subcutaneous injection three times daily x 7 days.
cyclophosphamide Cytoxan
40 mg/m^2 PO twice daily x 7 days.
rituximab Rituxan
375 mg/m^2 IV once weekly x 4 weeks.

Primary Outcomes

Measure
Response Rate
time frame: two months

Secondary Outcomes

Measure
After these drugs are given for 2 courses, a second goal is to see how long a remission lasts.
time frame: 10 Years
A third goal is to see how often repeat remissions can be achieved when the lymphoma returns later and the same drugs are restarted.
time frame: 10 Years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Primary Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab
Principal investigator Donna M. Weber, MD
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.