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| Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00670358 |
Purpose
RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. 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, doxorubicin, vincristine, and prednisone, 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 and combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with newly diagnosed stage II, stage III, or stage IV diffuse large cell or follicular B-cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: pegfilgrastim Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: lenalidomide Drug: prednisone Drug: vincristine sulfate Genetic: polymorphism analysis Other: laboratory biomarker analysis |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I/II Study of Lenalidomide (Revlimid), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R2CHOP) Chemoimmunotherapy in Patients With Newly Diagnosed Diffuse Large Cell and Follicular Grade IIIA/B B Cell Lymphoma |
| Estimated Enrollment: | 47 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I dose-escalation study of lenalidomide followed by a phase II study.
After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large cell or grade 3A/B follicular lymphoma
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259-5499 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Grzegorz S. Nowakowski, MD | Mayo Clinic |
| Investigator: | Craig B. Reeder, MD | Mayo Clinic Scottsdale |
More Information
| Responsible Party: | Mayo Clinic Cancer Center ( Grzegorz S. Nowakowski ) |
| Study ID Numbers: | CDR0000594812, MAYO-MC078E, CELGENE-RV-NHL-PI-0325 |
| Study First Received: | April 30, 2008 |
| Last Updated: | June 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00670358 History of Changes |
| Health Authority: | United States: Federal Government |
|
contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma |
contiguous stage II grade 3 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 3 follicular lymphoma |
|
Anti-Inflammatory Agents Prednisone Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Cyclophosphamide Follicular Lymphoma Hormones Lymphoma, B-Cell Anti-Bacterial Agents Lymphoma, Large-cell Lymphoma Alkylating Agents Lymphoma, Large B-Cell, Diffuse |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Rituximab Lenalidomide Vincristine Antimitotic Agents Immunosuppressive Agents Glucocorticoids Doxorubicin Lymphatic Diseases B-cell Lymphomas Tubulin Modulators Antineoplastic Agents, Alkylating Lymphoma, Non-Hodgkin Lymphoproliferative Disorders |
|
Anti-Inflammatory Agents Prednisone Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Lymphoma, B-Cell Therapeutic Uses Lymphoma Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Mitosis Modulators Lenalidomide Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases Neoplasms Tubulin Modulators |