Immunotherapy combo may outperform chemo in rare lymphoma
NCT ID NCT07678229
First seen Jul 01, 2026 · Last updated Aug 14, 2026 · Updated 5 times
Summary
This Phase 3 trial tests whether an immunotherapy-based regimen (sintilimab, pegaspargase, and anlotinib) works better than standard chemotherapy before a stem cell transplant in people with newly diagnosed, advanced extranodal NK/T-cell lymphoma. Participants are randomly assigned to one of two treatment paths. The study aims to see which approach leads to better event-free survival at two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sintilimab, pegaspargase, anlotinib, gemcitabine, etoposide, methotrexate, dexamethasone
- What this could lead to
- If successful, this could establish a more effective, less toxic frontline immunotherapy-based regimen for advanced NK/T-cell lymphoma, potentially improving long-term survival.
- What could go wrong
- This is a Phase 3 trial, but the experimental arm combines multiple drugs, which may increase side effects. The study is relatively small (150 participants), and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center,
RECRUITINGShanghai, Shanghai Municipality, 200433, China
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