This is a prospective, multicenter, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of golidocitinib in combination with an anthracycline-based regimen as first-line treatment for patients with previously untreated nodal T-follicular helper (TFH) cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
150mg, po, qd
50 mg/m² intravenously on Day 1 of each 21-day cycle
60-90 mg/m² intravenously on Day 1 of each 21-day cycle
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China
Complete response rate
Defined as the proportion of patients who achieve complete remission at the end of induction treatment.
Time frame: Up to 6 cycles (each cycle is 21 days)
Progression-free survival(PFS)
To investigate the preliminary anti-tumor efficacy.
Time frame: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Overall survival(OS)
To investigate the preliminary anti-tumor efficacy
Time frame: From the date of enrollment until the date of death from ant cause, assessed up to 24 months
Objective response rate (ORR)
The proportion of patients who achieve complete remission (CR) or partial remission (PR)
Time frame: Up to 6 cycles (each cycle is 21 days)
Duration of Response(DOR)
To investigate the preliminary anti-tumor efficacy
Time frame: The time from the patient's first efficacy assessment achieving CR or PR until disease progression, assessed up to 24 months
Adverse events
The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)
Time frame: Up to 28 days after the last dose of study treatment
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