Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma
Plain-language summary
This trial is testing XNW5004 tablets (an investigational oral drug) for patients with various types of peripheral T-cell lymphoma (PTCL) who have been newly diagnosed and have not yet received treatment. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. Patients are randomly assigned to different treatment groups. This trial does not currently have sites in the United States. The trial is currently recruiting patients.
Who can join (key eligibility)
- Age 18 Years to 75 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
XNW5004 combined with CHOP (incremental) (DRUG): The XNW5004 protocol has preset four dosage groups: 400mg, 800mg, 1200mg and 1600mg, administered twice daily (BID). The CHOP regimen is administered at a fixed dose, for a total of 6 cycles. After completing the combined treatment and without disease progression, the subjects will continue to receive XNW5004 at 1200mg BID for maintenance therapy. | XNW5004 combined with CHOEP (incremental) (DRUG): It is expected to conduct dose escalation studies for XNW5004 in combination with CHOEP using 1-3 dose groups. The CHOEP regimen will be administered at a fixed dose for a total of 6 cycles. After completing the combined treatment and without disease progression, the subjects will continue to receive XNW5004 at 1200mg BID for maintenance therapy. | XNW5004 combined with CHOP (extended) (DRUG): Those who received the combination treatment of XNW5004 and CHOP, and who did not experience disease progression after the combined treatment, will continue to receive maintenance treatment with XNW5004 at a dose of 1200mg twice daily. | XNW5004 combined with CHOEP (extended) (DRUG): Those who received the combination treatment of XNW5004 and CHOEP, and who did not experience disease progression after the combined treatment, will continue to receive maintenance treatment with XNW5004 at a dose of 1200mg twice daily.
XNW5004 combined with CHOP (incremental), XNW5004 combined with CHOEP (incremental), XNW5004 combined with CHOP (extended), XNW5004 combined with CHOEP (extended)
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details