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)
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete or partial remission of disease.
every 6 weeks
Lance Leopold, MD
Ascenta Therapeutics, Inc.
United States: Food and Drug Administration
|Hinsdale, Illinois 60521|
|Albany, Georgia 31701|
|Birmingham, Alabama 35294|
|Fountain Valley, California 92708|
|Albany, New York 12208|
|Nashville, Tennessee 37203-1632|
|Charlotte, North Carolina|
|South Burlington, Vermont|
|Charleston, South Carolina|