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| Sponsor: | University of Kentucky |
|---|---|
| Collaborator: |
Celgene Corporation |
| Information provided by: | University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT00901069 |
Purpose
This is a phase I, prospective, open label, dose escalation study of azacitidine in combination with rituximab, vincristine, and cyclophosphamide for the treatment of refractory lymphoma. The investigators expect to enroll 12-24 patients in this trial over a 2 year accrual period.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Hodgkin Disease Lymphoma, Non-Hodgkin |
Drug: Azacitidine with rituximab, vincristine, and cyclophosphamide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma: A Phase I Trial |
| Estimated Enrollment: | 24 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (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: John W Hayslip, M.D., MSCR | 859-323-8718 | jhays2@uky.edu |
| Contact: Jeri Reynolds, RN | 859-323-8528 | jzreyn0@uky.edu |
| United States, Kentucky | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
More Information
| Responsible Party: | John Hayslip, MD, MSCR, University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT00901069 History of Changes |
| Obsolete Identifiers: | NCT00589160 |
| Other Study ID Numbers: | 07-NHL-06-UK/CC |
| Study First Received: | May 11, 2009 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Azacitidine Rituximab Cyclophosphamide Vincristine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Tubulin Modulators Antimitotic Agents Mitosis Modulators |