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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Oral
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Chicago, Illinois, United States
Complete or partial remission of disease.
Time frame: every 6 weeks
Number of participants with adverse events.
Time frame: every 3 weeks
duration of response
Time frame: every 6 weeks
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Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
High Point, North Carolina, United States
Unnamed facility
Hilton Head Island, South Carolina, United States
Unnamed facility
Memphis, Tennessee, United States
...and 1 more locations