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Sponsored by: |
Ascenta Therapeutics |
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Information provided by: | Ascenta Therapeutics |
ClinicalTrials.gov Identifier: | NCT00275431 |
This is an open-label, multicenter, phase II study to evaluate the safety and efficacy of single-agent AT-101 in patients with relapsed or refractory B-cell malignancies.
Condition | Intervention | Phase |
---|---|---|
Follicular Lymphoma Diffuse Large Cell Lymphoma Mantle Cell Lymphoma Small Lymphocytic Lymphoma Chronic Lymphocytic Leukemia |
Drug: AT-101 |
Phase II |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Historical Control, Parallel Assignment |
Official Title: | A Phase II, Open Label, Multicenter Study of Single-Agent AT-101 in Patients With Relapsed or Refractory B-Cell Malignancies (Follicular Lymphoma, Mantle Cell Lymphoma, Diffuse Large Cell Lymphoma, or Small Lymphocytic Lymphoma/Chronic Lymphocytic Leukemia) |
Estimated Enrollment: | 82 |
Study Start Date: | November 2005 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
This is an open-label, multicenter, phase II study to evaluate the safety and efficacy of single-agent AT-101 in patients with relapsed or refractory B-cell malignancies. For the purpose of this study, B-cell malignancies can include one of the following disease sub-types: follicular lymphoma (FL), diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), small lymphocytic lymphoma (SLL)/chronic lymphocytic leukemia. Patients will be enrolled according to disease subtype into one of four groups in two stages. The first stage of each group will enrolled 13 patients. If patients within any group experience disease response, an additional 14 patients will be enrolled into that group.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Birmingham, Alabama, United States | |
United States, California | |
San Diego, California, United States | |
United States, Georgia | |
Atlanta, Georgia, United States | |
United States, Illinois | |
Chicago, Illinois, United States | |
United States, Massachusetts | |
Boston, Massachusetts, United States | |
United States, New York | |
New York, New York, United States | |
Rochester, New York, United States | |
United States, North Carolina | |
High Point, North Carolina, United States | |
United States, South Carolina | |
Hilton Head Island, South Carolina, United States | |
United States, Tennessee | |
Memphis, Tennessee, United States | |
United States, Vermont | |
Burlington, Vermont, United States |
Study Director: | Lance Leopold, MD | Ascenta Therapeutics, Inc. |
Study ID Numbers: | AT-101-CS-005 |
Study First Received: | January 10, 2006 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00275431 |
Health Authority: | United States: Food and Drug Administration |
cancer AT-101 AT101 B-cell malignancies |
Non-Hodgkin lymphoma lukemia |
Chronic lymphocytic leukemia Leukemia, Lymphoid Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia, B-cell, chronic Lymphoma, Mantle-Cell Lymphoma, Follicular Gossypol acetic acid Mantle cell lymphoma Gossypol Lymphoma, large-cell |
Lymphoma, B-Cell Leukemia Lymphatic Diseases Leukemia, Lymphocytic, Chronic, B-Cell B-cell lymphomas Leukemia, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents Contraceptive Agents Physiological Effects of Drugs Contraceptive Agents, Female Reproductive Control Agents |
Contraceptive Agents, Male Pharmacologic Actions Neoplasms Therapeutic Uses Antispermatogenic Agents Antineoplastic Agents, Phytogenic Spermatocidal Agents |