Plain-language summary

This Phase 3 trial is comparing different first-line treatment approaches for people newly diagnosed with NK/T-cell lymphoma. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

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

GELAD regimen (DRUG): Gemcitabine 1.0 g/m² on day 1, etoposide 60 mg/m² on days 1-3, pegaspargase 2000 IU/m² on day 4, and dexamethasone 40 mg on days 1-4, repeated every 21 days for 1 cycle. | MEDA regimen (DRUG): Methotrexate 3.0 g/m² on day 1 as a 3-hour intravenous infusion, etoposide 100 mg/m² on days 2-4, dexamethasone 40 mg on days 1-4, and pegaspargase 2500 IU/m² on day 4, repeated every 21 days for 3 cycles. | LEAP regimen (DRUG): Sintilimab 200 mg intravenously on day 1, pegaspargase 2500 IU/m² on day 1 with a maximum single dose of 3750 IU, and anlotinib 8 mg orally on days 1-14, repeated every 21 days for 4 cycles. | High-dose methotrexate (DRUG): Participants who achieve strict complete remission after LEAP induction will receive methotrexate 3.0 g/m² as a 3-hour intravenous infusion every 2 weeks for up to 3 doses, with hydration, urine alkalization, leucovorin rescue, and methotrexate concentration monitoring. | Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE): Participants achieving strict complete remission will undergo autologous hematopoietic stem cell transplantation according to institutional transplant procedures if eligible.

Drugs / treatments

GELAD regimen, MEDA regimen, LEAP regimen, High-dose methotrexate, Autologous Hematopoietic Stem Cell Transplantation

Treatment length

Ask the trial team for details

Visit frequency

Ask the trial team for details