Frontline immunotherapy versus chemotherapy induction for advanced Extranodal NK/T-cell lymphoma, followed by autologous stem cell transplant
Official title: BRIDGE-NK: A Randomized, Open-Label, Prospective Phase III Study of Immunotherapy Induction Versus Chemotherapy Induction Followed by Autologous Hematopoietic Stem Cell Transplantation Consolidation in Newly Diagnosed Advanced Extranodal NK/T-Cell Lymphoma
Run by Fudan University · NCT07678229 · Data updated 2026-11-12
This study tests whether starting with immunotherapy plus targeted drugs is more effective than standard chemotherapy to help patients with advanced extranodal NK/T‑cell lymphoma, then all patients who reach a strict remission proceed to autologous stem cell transplantation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | anlotinib, methotrexate, sintilimab, chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | August 11, 2026 |
| Main results expected | December 31, 2031 |
| Study ends | December 31, 2031 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT07678229 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with newly diagnosed, untreated stage IV EBER-positive extranodal NK/T-cell lymphoma and adequate organ function, able to undergo autologous stem cell transplantation.
✕Probably not a fit
Patients not achieving strict complete remission after induction or unable to proceed to CNS-directed consolidation may not receive the anticipated benefit from the strategy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized Phase 3 trial in adults with newly diagnosed stage IV extranodal NK/T-cell lymphoma. Participants are randomized 1:1 to receive either GELAD induction followed by MEDA chemotherapy or LEAP induction with sintilimab, pegylated asparaginase, and anlotinib, with both arms aiming for strict complete remission prior to autologous stem cell transplantation. Strict complete remission requires PET/CT metabolic silence, negative EBV DNA in plasma, and negative EBER staining on repeat bone marrow biopsy if applicable. The study evaluates the entire treatment strategy, including induction depth and feasibility of CNS-directed consolidation, to see if immunotherapy-based induction improves event-free survival compared with conventional chemotherapy induction. High-dose methotrexate–based CNS-directed consolidation followed by autologous transplantation is planned for those achieving remission in the immunotherapy arm, while the chemotherapy arm follows its consolidation pathway. Eligibility includes adults 18–70 with newly diagnosed, untreated, stage IV EBER-positive disease and adequate organ function.
Why it matters
Potential benefit: If successful, the immunotherapy-led strategy could improve event-free survival and provide a new frontline option for advanced NKTCL.
How similar studies have gone: Immunotherapy combinations have shown activity in advanced NKTCL, but randomized front-line comparisons against chemotherapy are limited; this trial tests a potentially practice-changing approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 to 70 years at the time of signing informed consent. * Histologically confirmed extranodal NK/T-cell lymphoma according to the current classification criteria, with tumor tissue confirmed to be EBER positive. Central pathology review is recommended. * Stage IV disease according to Lugano 2014 staging criteria, with baseline staging including PET/CT and bone marrow evaluation. * Previously untreated disease, with no prior systemic anti-lymphoma therapy, radiotherapy, or other anti-tumor treatment for NKTCL. * At least one evaluable lesion assessable by PET/CT and/or contrast-enhanced CT/MRI. * Eastern Cooperative Oncology Group performance status score of 0 to 3. * Adequate hematologic function during screening, defined as absolute neutrophil count ≥1.0 × 10\^9/L, hemoglobin \>80 g/L, and platelet count \>50 × 10\^9/L. * Adequate hepatic and renal function during screening, defined as alanine aminotransferase and aspartate aminotransferase ≤2 × upper limit of normal, total bilirubin ≤2 × upper limit of normal, and creatinine clearance ≥60 mL/min. * No severe uncontrolled coagulation disorder, and judged by the investigator to be able to receive pegaspargase-containing therapy. * Judged by the investigator to have no absolute contraindication to key components of the assigned treatment strategy, including irreversible contraindication to high-dose methotrexate, severe organ dysfunction precluding transplant evaluation, or other conditions clearly preventing completion of the protocol-defined strategy. * Written informed consent provided by the participant or legally authorized representative. Exclusion Criteria: * Prior systemic anti-lymphoma therapy, radiotherapy, or investigational anti-tumor therapy. * Active central nervous system lymphoma involvement, including active brain parenchymal, meningeal, cerebrospinal fluid, or intraocular involvement. * Active infection requiring intensive care support, or infection judged by the investigator to be uncontrolled and likely to significantly interfere with protocol treatment. * Known history of acute or chronic pancreatitis, or any condition judged by the investigator to be an absolute contraindication to pegaspargase. Fulminant disseminated intravascular coagulation, or severe coagulation disorder judged by the investigator to be uncorrectable in the short term and to substantially increase treatment risk. * Severe cardiac, pulmonary, hepatic, renal, or other major organ dysfunction that, in the investigator's judgment, would significantly interfere with protocol treatment. * Irreversible contraindication to high-dose methotrexate, including but not limited to marked renal failure, inability to receive standardized hydration, alkalization, leucovorin rescue, or methotrexate clearance monitoring, or any condition judged by the investigator to prevent safe administration of methotrexate within the protocol-defined strategy. * Active hepatitis C virus infection, human immunodeficiency virus infection, or active uncontrolled hepatitis B virus replication. * Uncontrolled severe hypertension, active bleeding, recent major thromboembolic event, or vascular high-risk condition judged by the investigator to preclude safe administration of anlotinib. * Pregnant or breastfeeding women, or participants of reproductive potential unwilling to use effective contraception during the study. * Any other medical, psychological, social, or compliance-related condition that, in the investigator's judgment, makes the participant unsuitable for this study.
Where it's running
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Fudan University Shanghai Cancer Center,
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Chuanxu Liu, MD & PhD — Shanghai Cancer Center
- Study coordinator: Rong Tao, MD & PhD
- Email: hkutao@hotmail.com
- Phone: 008621-64175590
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Epstein-Barr virus–positive T/NK-cell lymphoproliferative diseases in large patient groups
This study follows patients with EBV-positive T/NK-cell disorders to see how they present, what treatments are used, and how they respond over time.
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Tislelizumab plus Zeprumetostat in relapsed or refractory NK/T-cell lymphoma
This study tests whether combining tislelizumab with zeprumetostat can help patients with relapsed or refractory NK/T-cell lymphoma after prior chemotherapy.
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Treatment for untreated extranodal NK/T-cell lymphoma using a combination of drugs
This study is testing a new combination of drugs to see if it can help people with untreated extranodal NK/T-cell lymphoma feel better and improve their chances of survival.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.