Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00667329 |
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Recruitment Status :
Active, not recruiting
First Posted : April 28, 2008
Last Update Posted : January 18, 2020
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Drug: 2CdA Drug: Cyclophosphamide Drug: Rituximab | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Primary Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab |
| Actual Study Start Date : | July 9, 1999 |
| Estimated Primary Completion Date : | July 31, 2020 |
| Estimated Study Completion Date : | July 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
- Response Rate [ Time Frame: two months ]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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00667329 |
| Other Study ID Numbers: |
DM99-070 NCI-2020-00334 ( Registry Identifier: NCI CTRP ) |
| First Posted: | April 28, 2008 Key Record Dates |
| Last Update Posted: | January 18, 2020 |
| Last Verified: | January 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Waldenstrom's Macroglobulinemia Lymphoma 2CdA Cladribine Leustatin |
Cyclophosphamide Cytoxan Neosar Rituxan Rituximab |
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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Cladribine |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological |