This is a prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of golidocitinib combined with mitoxantrone hydrochloride liposome or chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
150mg, po, qd;
Cohort 1: 15 mg/m2, IV, D1 and 18 mg/m2, IV, D1 (phase Ib); RP2D (II study)
Cohort 2: Chidamide:20mg/30mg, po, Biw (phase Ib); RP2D (phase II study)
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGOverall response rate(ORR) for Phase 2
The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
Time frame: Up to 24 months
Maximum tolerated dose (MTD) for Phase 1b
To identify the MTD
Time frame: The first cycle after administration
Complete response rate (CRR)
Defined as the proportion of patients who achieve complete remission as the best response
Time frame: Up to 24 months
Duration of Response(DOR)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 4 years
Progression-free survival(PFS)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 4 years
Overall survival(OS)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 4 years
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