This is a Phase 2 study to assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.
University of Nebraska Medical Center
Omaha, Nebraska, United States
Weill Medical College of Cornell
New York, New York, United States
University of Rochester James P. Wilmot Cancer Center
Rochester, New York, United States
MD Anderson Cancer Canter
Houston, Texas, United States
Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy
Outcome Measure - To assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphophasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).
Time frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication
Assess durability of response
To assess the durability of response following SB1518 treatment in patients with advanced lymphoid malignancies.
Time frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication
Assess number of patients with adverse events as a measure of safety and tolerability
To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies.
Time frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication
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University of British Columbia
Vancouver, British Columbia, Canada