Can a Triple-Drug combo tame an aggressive lymphoma without harsh chemo?
NCT ID NCT04004572
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a combination of three drugs—sintilimab, pegaspargase, and anlotinib—can effectively treat stage IV extranodal NK/T-cell lymphoma in patients who are not healthy enough for high-intensity chemotherapy. The study enrolls adults with newly diagnosed or relapsed disease and evaluates how many achieve a complete response after 24 weeks of treatment. The goal is to find a safer, yet effective, alternative for this challenging condition.
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 three drugs: sintilimab (an immunotherapy), pegaspargase (a chemotherapy agent), and anlotinib (a targeted therapy)
- What this could lead to
- If successful, this combination could offer a gentler, effective treatment option for people with advanced NK/T-cell lymphoma who cannot tolerate standard high-intensity chemotherapy.
- What could go wrong
- This is a small, early-phase trial, so results may not hold up in larger studies. The drug combination may cause side effects, and not all patients may respond.
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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37 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Dec 2024
- 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 years and older
- 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: * Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria. * Stage IV disease according Lugano 2014 staging system. Newly diagnosed patients, or relapsed disease without a history of asparaginase-containing regimen. * PET/CT or CT/MRI with at least one objectively evaluable lesion. * The age is greater than 65 years old. Those who are younger than 65 years should have a documented history unfit for high-dose combination chemotherapy (ie. high doses of methotrexate or high doses of dexamethasone, or autologous hematopoietic stem cell transplantation). * General status ECOG score 0-3 points. * The laboratory test within 1 week before enrollment meets the following conditions: Blood routine: Hb\>80g/L, PLT\>50×109/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Coagulation : plasma fibrinogen ≥ 1.0g / L. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking. * Sign the informed consent form. * Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations. Exclusion Criteria: * Patients with a history of pancreatitis. * Active infection requires ICU treatment. * Concomitant HCV or HIV infection. Patients who are infected with HBV at the same time are not excluded. * Serious complications such as fulminant DIC. * Significant organ dysfunction: such as respiratory failure, NYHA classification ≥ 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 months. * Pregnant and lactating women. * Had a history of autoimmune diseases, and disease was active in the last 6 months, and was still taking oral immunosuppression in the past three months. For the treatment, the daily dose of oral prednisone is greater than 10 mg. * Those who were known to be allergic to drugs in the study regimen. * Patients with other tumors who require surgery or chemotherapy within 6 months. * Other experimental drugs are being used.
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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.
Contacts and locations
Locations
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Xinhua Hospital
Shanghai, Shanghai Municipality, 200092, China
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