This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of golidocitinib and benmelstobart combination treatment in patients with relapsed or refractory extranodal natural killer/T cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
150 mg, administered once daily from Day 1 to Day 21 (D1-D21)
1200 mg, administered on Day 1 (D1) of every cycle
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGObjective response rate(ORR)
The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
Time frame: 2 years
Complete Response(CR)
Defined as the proportion of patients who achieve complete remission as the best response
Time frame: 2 years
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
Incidence and severity of adverse events (AE) , Serious adverse event (SAE) and immune-related adverse event (irAE)
To identify the incidence of AE, SAE, and irAE.
Time frame: Through study completion, up tp 2 years.
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