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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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | Francine Foss, M.D., Principal Investigator, Yale University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00337987 History of Changes |
| Other Study ID Numbers: | 0507000369 |
| Study First Received: | June 15, 2006 |
| Last Updated: | June 5, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Denileukin diftitox 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 Hormones, Hormone Substitutes, and Hormone Antagonists |