BRIDGE-NK: Immunotherapy Versus Chemotherapy Induction Followed by Autologous HSCT in Advanced NKTCL
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a randomized, open-label, prospective, multicenter phase III superiority study in patients with newly diagnosed stage IV extranodal NK/T-cell lymphoma. The study compares two frontline induction strategies followed by consolidation with autologous hematopoietic stem cell transplantation in patients who achieve a protocol-defined strict complete remission. Eligible participants will be randomized 1:1 to Arm A or Arm B, stratified by three-level PINK-E risk category. Arm A consists of one cycle of GELAD induction followed by three cycles of MEDA chemotherapy. Participants who achieve strict complete remission after key response assessment will proceed to autologous hematopoietic stem cell transplantation consolidation. Arm B consists of four cycles of LEAP induction with sintilimab, pegaspargase, and anlotinib. Participants who achieve strict complete remission will receive high-dose methotrexate CNS-directed consolidation followed by autologous hematopoietic stem cell transplantation consolidation if eligible. The primary endpoint is event-free survival within 24 months after randomization. Secondary endpoints include progression-free survival, overall survival, overall response rate, complete remission rate, strict complete remission rate, autologous hematopoietic stem cell transplantation completion rate, cumulative incidence of relapse, grade 3 or higher adverse events, treatment discontinuation, treatment-related mortality, and plasma EBV-DNA clearance dynamics.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek od 18 do 70 lat
- •Potwierdzony histologicznie chłoniak NK/T z pozytywnym wynikiem testu EBER
- •Zaawansowana choroba (etap IV) potwierdzona badaniami obrazowymi
- •Brak wcześniejszego leczenia tego chłoniaka
- •Dostateczna funkcja nerek, wątroby i szpiku kostnego
- •Zdolność do otrzymania leczenia zawierającego pegaspargazę
✗ Disqualifies
- •Wcześniejsze leczenie tego chłoniaka
- •Zajęcie mózgu lub opon mózgowych chłoniakiem
- •Poważna aktywna infekcja wymagająca intensywnej opieki
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- August 13, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Fudan University Shanghai Cancer Center,
Shanghai, China
Trial contact
Rong Tao, MD & PhD
Chuanxu Liu, MD & PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/14/2026.
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