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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
Eisai Inc. |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00337987 |
Purpose
The standard treatment for PTCL is CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy. This study is attempting to determine whether adding other treatments to CHOP therapy will improve the chance of the disease going into remission or staying in remission. Because other drugs for T-cell lymphoma have not yet been given with CHOP, this study is looking at combining CHOP with ONTAK. ONTAK has been FDA approved for treatment of Cutaneous T cell Lymphoma and works by specifically binding to a protein on the surface of the tumor cells and killing the cell without causing damage to other types of cells in the body. Studies have shown that ONTAK has helped patients with PTCL who have failed chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral T-Cell Lymphoma |
Drug: Ontak Drug: CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Pilot Phase II Study to Determine the Safety of the Combination of ONTAK (DAB389IL-2), an Interleukin-2 Fusion Toxin, in Combination With CHOP in Peripheral T-Cell Lymphoma |
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Noelle Sowers, R.N. | 203-785-2442 | noelle.sowers@yale.edu |
| Contact: Donna LaCivita | 203-737-2579 | donna.lacivita@yale.edu |
| United States, Connecticut | |
| Yale Comprehensive Cancer Center at Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Principal Investigator: | Francine Foss, M.D. | Yale University |
More Information
| Responsible Party: | Yale University School of Medicine ( Francine Foss, M.D., Principal Investigator ) |
| Study ID Numbers: | 0507000369 |
| Study First Received: | June 15, 2006 |
| Last Updated: | June 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00337987 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anti-Inflammatory Agents Prednisone Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Hormones Lymphoma, T-Cell, Peripheral Lymphoma, T-Cell 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 Pharmacologic Actions Lymphatic Diseases Neoplasms Denileukin diftitox Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating |