Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: 2CdA (Drug); Cyclophosphamide (Drug); Rituximab (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): Donna M. Weber, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center
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.
Clinical Details
Official title: Primary Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response Rate
Secondary outcome: 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.
Detailed 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).
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
The University of Texas M.D.Anderson Cancer Center
Starting date: July 1999
Last updated: September 8, 2014
|