Golidocitinib Combined With P-GemOx Plus PD-1 Inhibitor Versus P-GemOx Plus PD-1 Inhibitor in First-Line Newly Diagnosed Advanced or Non-Nasal Extranodal NK/T-Cell Lymphoma
Plain-language summary
This trial is testing an asparaginase-based regimen for patients with extranodal NK/T-cell lymphoma (ENKTL) who have been newly diagnosed and have not yet received treatment as well as those who have responded to prior therapy and may receive maintenance treatment. This is a Phase 2 trial, which means researchers are studying how well the treatment works and monitoring for side effects. Patients are randomly assigned to different treatment groups. This trial does not currently have sites in the United States. The trial is not yet open for recruitment.
Who can join (key eligibility)
- Age 18 Years to 70 Years years
- Newly diagnosed, not yet treated
- Must be well enough for treatment (adequate performance status)
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
Golidocitinib in combination with P-GEMOX and PD-1 inhibitor (DRUG): Participants receive this combination for 6 cycles of induction therapy. Those achieving complete response (CR) or partial response (PR) post-induction will continue maintenance therapy with golidocitinib plus PD-1 inhibitor (same dosage and administration schedule) for 1 year, or until disease progression, unacceptable toxicity, or voluntary withdrawal from the study. This regimen is designed to target the STAT3 signaling pathway (via golidocitinib) while combining cytotoxic chemotherapy (P-GEMOX) and immune checkpoint inhibition (PD-1 inhibitor) for synergistic anti-lymphoma activity. | PD-1 inhibitor in combination with P-GEMOX (DRUG): Participants receive this combined regimen for 6 cycles of induction therapy. For those achieving complete response (CR) or partial response (PR) post-induction, maintenance therapy is continued with PD-1 inhibitor alone (same 200 mg intravenous dose on Day 1 of each 21-day cycle) for 1 year, or until disease progression, unacceptable treatment-related toxicity, or study discontinuation. This regimen represents a currently established first-line therapeutic option for advanced/non-nasal ENKTL, serving as the active comparator for evaluating the added benefit of golidocitinib in the experimental arm.
Golidocitinib in combination with P-GEMOX and PD-1 inhibitor, PD-1 inhibitor in combination with P-GEMOX
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details