A Phase 2 interventional study of Golidocitinib and Doxorubicin in Nodal T-follicular Helper Cell Lymphoma, sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
Key inclusion Criteria:
Key exclusion Criteria:
Participants will receive golidocitinib 150 mg orally once daily in combination with either doxorubicin 50 mg/m² intravenously on Day 1 or epirubicin 60-90 mg/m² intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Participants who achieve a complete response (CR) or partial response (PR) may receive golidocitinib monotherapy as maintenance treatment for up to 12 months, as determined by the investigator.
Drug: Golidocitinib · Drug: Doxorubicin · Drug: Epirubicin
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
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
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University