BRIDGE-NK: Immunotherapy Versus Chemotherapy Induction Followed by Autologous HSCT in Advanced NKTCL
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 3 trial, which means the treatment is being compared to the current standard of care to determine if it works better. 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
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.
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