Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lymphoma |
Drug: 2CdA Drug: Cyclophosphamide Drug: Rituximab |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Primary Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab |
- Response Rate [ Time Frame: two months ] [ Designated as safety issue: No ]Response defined as at least 50% reduction of monoclonal IgM synthesis for at least two months with more than 50% reduction of tumor infiltrates at all involved sites (bone marrow, lymph nodes, spleen etc.). Complete response defined as disappearance of abnormal protein by immunofixation, resolution of lymphadenopathy and splenomegaly, less than 20% lymphocytes in bone marrow and no evidence of monoclonal lymphocytes.
- After these drugs are given for 2 courses, a second goal is to see how long a remission lasts. [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 1999 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 2CdA + Cyclophosphamide + Rituximab
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.
|
Drug: 2CdA
1.5 mg/m^2 subcutaneous injection three times daily x 7 days.
Other Names:
Drug: Cyclophosphamide
40 mg/m^2 PO twice daily x 7 days.
Other Names:
Drug: Rituximab
375 mg/m^2 IV once weekly x 4 weeks.
Other Name: Rituxan
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Patients must have adequate liver function (bilirubin <2.5 mg%) and renal function (creatinine <2.0 mg%).
Exclusion Criteria:
None.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00667329
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Donna M. Weber, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00667329 History of Changes |
| Other Study ID Numbers: | DM99-070, NCI-2010-01457 |
| Study First Received: | April 24, 2008 |
| Last Updated: | September 8, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Waldenstrom's Macroglobulinemia Lymphoma 2CdA Cladribine Leustatin |
Cyclophosphamide Cytoxan Neosar Rituxan Rituximab |
Additional relevant MeSH terms:
|
Cyclophosphamide Rituximab Alkylating Agents Antineoplastic Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Immunologic Factors |
Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015