New hope for lymphoma patients who Can't take chemo
NCT ID NCT04417166
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether combining the immunotherapy drug pembrolizumab (Keytruda) with targeted radiation can control a rare type of lymphoma called NK/T-cell lymphoma. It enrolls 30 patients with early-stage disease who are not healthy enough for standard chemotherapy. Participants receive radiation plus pembrolizumab every 3 weeks, followed by up to 2 years of maintenance therapy. The main goal is to see how many patients remain cancer-free after 2 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pembrolizumab (Keytruda) and radiation therapy
- What this could lead to
- If successful, this combination could offer an effective chemotherapy-free treatment option for patients with this rare lymphoma who cannot tolerate standard chemo.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply broadly. The long-term safety and effectiveness are still unknown.
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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30 people
The number who actually took part.
- Started
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Feb 2022
- Expected to finish
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Dec 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.
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: * Confirmed histological diagnosis of NK/T Cell Lymphoma * No previous anti-lymphoma treatment * Age ≥ 18 years * Ann Arbor stage I-II * At least one measurable/evaluable site after diagnostic biopsy before treatment start * At least one of the following high-risk features: age \> 60 years, elevated LDH, stage II, primary tumor invasion * Patient ineligible to receive full dose standard chemotherapy * ECOG performance status of 0-1 * Signed Informed consent * Ability to comply with the protocol * Adequate hematological and organ function; * Tumor tissue (fresh preferred, archival tissue is also acceptable) * For women of childbearing potential a negative pregnancy test on day 1 of cycle 1 and agree to adopt an adequate measure to avoid pregnancy during study treatment and for at least one year from end of treatment * For men agreement to remain abstinent or to use barrier contraception Exclusion Criteria: * Advanced stage disease (AA stage III-IV) * Extranasal type NKTCL * History of autoimmune disease * History of other(s) infiltrating cancer(s) in the previous 3 years that were not treated with curative intent or who are still receiving anticancer therapy (including hormone therapy for breast or prostate cancer). * History of (non-infectious) pneumonitis that required steroids; evidence of interstitial lung disease or active, non-infectious pneumonitis * Active infection requiring systemic therapy * Significant cardiovascular disease, myocardial infarction in the previous 3 months, unstable arrhythmias, or unstable angina. * Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent * HBsAg, HCV or HIV positivity. Positive serology is admitted for HBV and HCV but DNA/RNA test must be negative * Administration of a live attenuated vaccine within 4 weeks before cyle 1 day 1. Patients must not receive live, attenuate vaccines, including influenza vaccines at any time during study. * Treatment with systemic immunosuppressive medications, including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and anti tumor necrosis factor (anti-TNF) agents within 2 weeks prior to cycle 1 day 1; inhaled corticosteroids are allowed. * Evidence of suspect of CNS disease * Clinically significant hypersensitivity (e.g., anaphylactic or anaphylactoid reactions to the compound Pembrolizumab itself or to the excipients in its formulation). * Has had an allogenic tissue/solid organ transplant * Known history of active TB (Bacillus Tuberculosis)
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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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Shanghai Rui-Jin Hospital
Shanghai, 200025, China
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Sun Yat-sen University Cancer Center
Guangzhou, China