The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
SHR2554 with CHOP
SHR2554 with CHOEP
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGSafety endpoints: incidence and severity of adverse events (AEs)
Ib phase
Time frame: through study completion, an average of about 6 months
Overall response rate (ORR)
II phase
Time frame: 90 days since the date of first dose
Plasma concentration
Ib phase
Time frame: Day 1 of cycle 1 to day 1 of cycle 4 (21 days/cycle)
Progression Free Survival (PFS)
II phase
Time frame: through study completion, an average of about 6 months
Overall Survival (OS)
II phase
Time frame: 2 years since the date of first dose
Duration of response (DOR)
II phase
Time frame: through study completion, an average of about 6 months
Incidence and severity of adverse events (AEs)
II phase
Time frame: through study completion, an average of about 6 months
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