New drug combo shows promise for rare, aggressive blood cancer
NCT ID NCT06583083
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the immunotherapy drug sintilimab to standard chemotherapy can help people with a rare and aggressive type of lymphoma (NK/T-cell lymphoma) that has spread. About 84 newly diagnosed patients will be randomly assigned to receive either the combination or chemotherapy alone. The goal is to see if the combination delays cancer growth and is safe.
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 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Aug 2026
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 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Pathologically diagnosed with ENKTL. 2. Advanced stage. 3. Has at least one measurable or assessable lesion. 4. Age \> 18 years, no gender restrictions, with an expected survival of more than 3 months. 5. Willing to participate in the clinical study; fully informed and has signed a written informed consent form. 6. Adequate organ and bone marrow function. Exclusion Criteria: 1. Aggressive NK-cell leukemia. 2. Central nervous system involvement. 3. Patients with significant dysfunction of vital organs. 4. History of allergy to the investigational drug, similar drugs, or excipients. 5. Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes). 6. Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception. 7. Active infection, excluding fever related to tumor-associated B symptoms. 8. Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
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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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Sun Yat-sen Universitiy Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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