Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/26/2018 |
| Start Date: | July 1999 |
| End Date: | July 2019 |
Primary 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).
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.
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:
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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