This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the efficacy, safety/ tolerability and pharmacokinetic of GFH009 monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
95
patients are planned to be administrated with GFH009 every week in a 21 days cycle, intravenous infusion
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China
RECRUITINGPhase Ib: adverse events
Incidence of intolerable toxic events, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months)
Phase II: Objective Response Rate
ORR(Objective Response Rate)
Time frame: From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months)
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