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Sponsored by: |
Ohio State University Comprehensive Cancer Center |
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Information provided by: | Ohio State University Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00323323 |
Purpose: This study will evaluate the safety of CHOP plus Alemtuzumab in patients with T/NK cell lymphomas and CD-20 negative large B-cell lymphomas who have not had previous treatments. The biological response of lymphoma cells and the immune system to this drug combination will also be measured in patients before, during, and after therapy administration.
Condition | Intervention | Phase |
---|---|---|
Non-Hodgkin's Lymphoma |
Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Alemtuzumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas |
Estimated Enrollment: | 34 |
Study Start Date: | March 2004 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Rationale: The drug combination called CHOP, or Cyclophosphamide (Cytoxan), Doxorubicin (Adriamycin), Vincristine (Oncovin), and Prednisone (Deltasone), has been used against different types of lymphoma for many years. Researchers are investigating what other therapies to combine with the CHOP regimen to improve outcomes for patients with lymphoma. The current study combines CHOP with alemtuzumab, a monoclonal antibody used against leukemia. Monoclonal antibodies are a type of immunotherapy used against some types of cancer. They are produced in a laboratory and designed to target as well as bind with cells that carry specific proteins. Alemtuzumab is designed to target leukemia cells that express a specific protein. The specific protein recognized by alemtuzumab is the CD52 antigen. This antigen, or substance that causes the immune system to create a specific response, is expressed on normal B and T cells, as well as on abnormal T cells characteristic of certain cancers. Alemtuzumab causes the CD52 antigen to bind with B-cell lymphocytes. This study will also assess the theory that alemtuzumab may increase the effectiveness of the chemotherapy agents included in the CHOP regimen.
Treatment: Patients in this study will receive alemtuzumab and CHOP. Alemtuzumab will be given through injections into the skin and CHOP will be administered through intravenous infusions. Patients will receive alemtuzumab alone during the first week of the study. An increasing amount of alemtuzumab will be given during the first week. If patients cannot tolerate the highest amount of alemtuzumab determined as appropriate within one week, they will be removed from the study. Once the highest dose of alemtuzumab has been achieved, patients will then receive both alemtuzumab and CHOP every three weeks. This schedule will be repeated up to eight times. Several tests and exams will be given throughout the study to closely monitor patients.
Treatments will be discontinued due to disease growth or unacceptable side effects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ohio State University Cancer Clinical Trial Matching Service | 866-627-7616 | osu@emergingmed.com |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Pierluigi Porcu | Ohio State University |
Responsible Party: | Ohio State University Comprehensive Cancer Center ( Pierluigi Porcu, M.D. ) |
Study ID Numbers: | OSU-0303 |
Study First Received: | May 8, 2006 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00323323 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Untreated CD-20 Negative Large B-Cell Lymphomas |
Anti-Inflammatory Agents Prednisone Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Hormones Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Anti-Bacterial Agents Alemtuzumab Aggression Lymphoma Alkylating Agents Immunoproliferative Disorders |
Antineoplastic Agents, Hormonal Vincristine Antimitotic Agents Immunosuppressive Agents Glucocorticoids Doxorubicin Lymphatic Diseases B-cell Lymphomas Tubulin Modulators Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents Antineoplastic Agents, Phytogenic |
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 Alemtuzumab Therapeutic Uses Lymphoma Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating |