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Sponsors and Collaborators: |
Mayo Clinic Scottsdale National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00784927 |
RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with rituximab, cyclophosphamide, and dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab, cyclophosphamide, and dexamethasone works in treating patients with previously untreated low-grade non-Hodgkin lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: cyclophosphamide Drug: dexamethasone Drug: lenalidomide Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study of Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone (LR-CD) for Untreated Low Grade Non-Hodgkin Lymphoma Requiring Therapy |
Estimated Enrollment: | 31 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral lenalidomide once daily on days 1-21, rituximab IV on day 1, oral cyclophosphamide once daily on days 1, 8, and 15, and oral dexamethasone once daily on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed symptomatic non-Hodgkin lymphoma by biopsy within the past 6 months
Any of the following subtypes allowed:
Measurable disease by CT or MRI scans with lymph nodes ≥ 2.0 cm in ≥ 1 dimension
WM patients without lymphadenopathy must meet the following criteria:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Arizona | |
Mayo Clinic Scottsdale | Recruiting |
Scottsdale, Arizona, United States, 85259-5499 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Study Chair: | Craig B. Reeder, MD | Mayo Clinic Scottsdale |
Investigator: | Thomas E. Witzig, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic Scottsdale ( Clinical Trials Office ) |
Study ID Numbers: | CDR0000617788, MAYO-MC0882, CELGENE-RV-NHL-PI-0336, MAYO-08-001485 |
Study First Received: | November 1, 2008 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00784927 |
Health Authority: | Unspecified |
stage I grade 1 follicular lymphoma contiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma stage III grade 1 follicular lymphoma stage IV grade 1 follicular lymphoma stage I grade 2 follicular lymphoma contiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 2 follicular lymphoma stage I small lymphocytic lymphoma contiguous stage II small lymphocytic lymphoma |
noncontiguous stage II small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma Waldenstrom macroglobulinemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma stage I marginal zone lymphoma contiguous stage II marginal zone lymphoma noncontiguous stage II marginal zone lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma |
Dexamethasone Chronic lymphocytic leukemia Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Lenalidomide Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Cyclophosphamide Lymphoma, B-Cell |
Lymphatic Diseases Waldenstrom Macroglobulinemia Leukemia, Lymphocytic, Chronic, B-Cell B-cell lymphomas Waldenstrom macroglobulinemia Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Dexamethasone acetate Follicular lymphoma |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Hormones |
Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neoplasms Autonomic Agents Therapeutic Uses Myeloablative Agonists Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Central Nervous System Agents Alkylating Agents |