Personalized lymphoma therapy: could lower radiation be enough?
NCT ID NCT07768943
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This trial is testing a personalized approach for people with early-stage extranodal NK/T-cell lymphoma, a rare cancer of the immune system. All participants receive two cycles of induction chemotherapy (GELAD), then doctors check how well the tumor responded using a PET/CT scan and a blood test for Epstein-Barr virus DNA. Based on that early response, patients are assigned to different treatment paths: some get standard or reduced-dose radiation, while others receive an additional immunotherapy drug called sintilimab. The goal is to see if adjusting treatment based on early response can maintain high progression-free survival while potentially reducing unnecessary radiation exposure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of gemcitabine, etoposide, dexamethasone, and pegaspargase (GELAD), with or without radiotherapy and sintilimab, adjusted based on early response.
- What this could lead to
- If successful, this could show that some patients with early-stage NK/T-cell lymphoma can safely receive lower-dose radiation, reducing side effects while maintaining disease control.
- What could go wrong
- This is a phase 2 trial, so results are preliminary. The reduced radiation dose might not be as effective, and the immunotherapy consolidation may not improve outcomes for high-risk 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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 620 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2036
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 75 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 75 years, inclusive. * Histologically confirmed extranodal NK/T-cell lymphoma, nasal type, according to the 2022 World Health Organization classification. * Diagnosis confirmed by institutional or central pathological review. Tumor tissue must be adequate for morphological assessment, immunohistochemistry, and Epstein-Barr virus-encoded RNA in situ hybridization. * Lugano 2014 stage IE or IIE disease with a primary site in the upper aerodigestive tract, including but not limited to the nasal cavity, paranasal sinuses, nasopharynx, oropharynx, or oral cavity. * At least one disease lesion evaluable by PET/CT at baseline. * No previous chemotherapy, radiotherapy, immunotherapy, or other antitumor biological therapy for lymphoma. * Eastern Cooperative Oncology Group performance status of 0 to 2. * Adequate organ function, including: * Absolute neutrophil count at least 1.0 x 10\^9/L. * Platelet count at least 75 x 10\^9/L. * Hemoglobin at least 90 g/L. * No granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion within 14 days before enrollment. * Total bilirubin no greater than 1.5 times the upper limit of normal. * Alanine aminotransferase and aspartate aminotransferase no greater than 2 times the upper limit of normal. * Serum creatinine no greater than 1.5 times the upper limit of normal. * Fibrinogen at least 1.5 g/L. * Left ventricular ejection fraction at least 50%. * Ability to understand the study and provide written informed consent. * Willingness to comply with protocol treatment, follow-up, laboratory testing, imaging assessments, and biospecimen collection. Exclusion Criteria: * Diagnosis not meeting the 2022 World Health Organization criteria for extranodal NK/T-cell lymphoma or not confirmed after pathological review. * Lugano stage III or IV disease or distant organ involvement inconsistent with localized early-stage disease. * Primary disease outside the upper aerodigestive tract or predominantly systemic or widespread extranodal disease. * Previous lymphoma-directed chemotherapy, radiotherapy, immunotherapy, or other systemic antitumor treatment. * Human immunodeficiency virus infection, active hepatitis C virus infection, or hepatitis B virus infection with HBV DNA greater than 10\^3/mL. * History of pancreatitis or pancreatic disease considered unsuitable for pegaspargase treatment. * Acute or systemic infection requiring intravenous anti-infective treatment. * Severe complications including hemophagocytic lymphohistiocytosis or disseminated intravascular coagulation. * Significant organ dysfunction, including respiratory failure, chronic congestive heart failure of New York Heart Association class II or higher, decompensated hepatic or renal dysfunction, uncontrolled hypertension or diabetes despite appropriate treatment, or cardiovascular or cerebrovascular thrombosis or bleeding within the previous 6 months. * Active autoimmune disease or another condition considered by the investigator to make immune checkpoint inhibitor treatment unsuitable. * Pregnancy or breastfeeding. * Participants of reproductive potential who are unwilling to use adequate contraception. * Known severe hypersensitivity to any study drug or its excipients. * Another active malignancy within the previous 6 months requiring surgery, radiotherapy, or systemic anticancer therapy. * Severe psychiatric disorder, poor adherence, or another condition that, in the investigator's judgment, would prevent completion of protocol treatment or follow-up. * Current use of another investigational drug or participation in another interventional clinical trial within 4 weeks before enrollment.
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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
Shanghai, Shanghai Municipality, 200032, China
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