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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Mayo Clinic |
| 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: | Primary Purpose: 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: | September 2015 (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.
Blood is collected at baseline, before course 3, and after completion of study treatment for translational research studies. Research studies include immune function and cytokine analysis, T- and B- quantitative lymphocyte analysis, and single nucleotide polymorphism analysis.
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 in Arizona | Recruiting |
| Scottsdale, Arizona, United States, 85259-5499 | |
| Contact: Mayo Clinic Clinical Trials Office 507-538-7623 | |
| Principal Investigator: Craig B. Reeder, M.D. | |
| United States, Florida | |
| Mayo Clinic in Florida | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Mayo Clinic Clinical Trials Office 507-538-7623 | |
| Principal Investigator: Candido E. Rivera, M.D. | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Mayo Clinic Clinical Trials Office 507-538-7623 | |
| Principal Investigator: Grzegorz S. Nowakowski, M.D. | |
| Study Chair: | Grzegorz S. Nowakowski, M.D. | Mayo Clinic |
| Principal Investigator: | Craig B. Reeder, M.D. | Mayo Clinic in Arizona |
| Principal Investigator: | Candido E. Rivera, M.D. | Mayo Clinic in Florida |
| Study Chair: | Judy Olmos, R.N. | Mayo Clinic in Florida |
| Study Chair: | Michele Maharaj, R.N. | Mayo Clinic in Florida |
More Information
| Responsible Party: | Grzegorz S. Nowakowski, M.D., Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00670358 History of Changes |
| Other Study ID Numbers: | CDR0000594812, P30CA015083, MC078E, RV-NHL-PI-0325, 07-007992, NCI-2009-01196 |
| Study First Received: | April 30, 2008 |
| Last Updated: | September 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
|
Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Thalidomide Rituximab Lenalidomide Doxorubicin Prednisone |
Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Glucocorticoids Hormones |