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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-00334 | Registry Identifier | NCI CTRP |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2CdA + Cyclophosphamide + Rituximab | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2CdA | Drug | 1.5 mg/m^2 subcutaneous injection three times daily x 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | 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. | two months |
| Measure | Description | Time Frame |
|---|---|---|
| After these drugs are given for 2 courses, a second goal is to see how long a remission lasts. | 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. | 10 Years |
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Inclusion Criteria:
Exclusion Criteria:
None.
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| Name | Affiliation | Role |
|---|---|---|
| Donna M. Weber, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| The University of Texas M.D.Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017338 | Cladribine |
| D003520 | Cyclophosphamide |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D015762 | 2-Chloroadenosine |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
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| Cyclophosphamide | Drug | 40 mg/m^2 PO twice daily x 7 days. |
|
|
| Rituximab | Drug | 375 mg/m^2 IV once weekly x 4 weeks. |
|
|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003839 | Deoxyadenosines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |