The primary purpose of this study is to evaluate the anti-tumor activity of TLN-254 monotherapy in participants with relapsed or refractory T-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Stanford Cancer Institute
Stanford, California, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
Percentage of Participants With Objective Response
Time frame: Up to 2 years
Percentage of Participants With CR
Time frame: Up to 2 years
Percentage of Participants With PR
Time frame: Up to 2 years
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 2 years
Number of Participants With Severity of TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Time frame: Up to 2 years
Plasma concentrations of TLN-254
Time frame: Day 1 of Cycle 1 and Day 1 of each even numbered Cycle for up to 2 years (Each Cycle length =28 days)
Duration of Response (DOR)
Time frame: Up to 2 years
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Sarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGBritish Columbia Cancer Agency
Vancouver, British Columbia, Canada
RECRUITING