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Brief Title: Phase II Safety and Efficacy Study of Single-agent AT-101 in Patients With Relapsed or Refractory B-cell Malignancies
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)
Study ID: NCT00275431
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Birmingham, Alabama, United States
, San Diego, California, United States
, Atlanta, Georgia, United States
, Chicago, Illinois, United States
, Boston, Massachusetts, United States
, New York, New York, United States
, Rochester, New York, United States
, High Point, North Carolina, United States
, Hilton Head Island, South Carolina, United States
, Memphis, Tennessee, United States
, Burlington, Vermont, United States
Name: Lance Leopold, MD
Affiliation: Ascenta Therapeutics, Inc.
Role: STUDY_DIRECTOR