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Can an immunotherapy combo boost remission in a rare lymphoma?

NCT ID NCT05254899

Cure Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This phase II trial is testing whether adding the immunotherapy drug tislelizumab to a chemotherapy regimen (pegaspargase, gemcitabine, and oxaliplatin) plus radiation can improve outcomes for people with early-stage, intermediate- or high-risk extranodal NK/T-cell lymphoma. The study will measure how many patients achieve a complete response after three cycles of the induction treatment, and will also track survival, side effects, and quality of life over two to five years. Participants must have newly diagnosed, stage I-II disease with at least one risk factor, such as elevated LDH or stage II disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tislelizumab (an anti-PD-1 immunotherapy) combined with pegaspargase, gemcitabine, oxaliplatin, and involved-site radiation therapy
What this could lead to
If successful, this combination could become a more effective first-line treatment for early-stage high-risk NK/T-cell lymphoma, potentially increasing the chance of complete remission and long-term survival.
What could go wrong
This is a phase II trial with a small number of participants, so results may not be definitive. The combination may cause significant side effects, and the complete response rate might not be better than existing treatments.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

54 people

The number who actually took part.

Started

Nov 2021

Finished

Mar 2026

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Biopsy proved extranodal NK/T cell lymphoma * No previous anti-cancer treatment * Measurable lesion on baseline PET/CT and MRI * Stage I-II * Have at lest one following risk factor: Elevated serum LDH level; PTI+; stage II * ECOG PS 0-1 * Sufficient organ functions Exclusion Criteria: * Other mature T- or NK- lymphoma * Hemophagocytic lymphohistiocytosis * Primary CNS lymphoma or CNS-involved lymphoma * History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment

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Conditions

The condition(s) this trial relates to.

extranodal nasal NK/T cell lymphoma Lymphoma, Extranodal NK-T-Cell

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early-stage Extranodal NK-T-cell lymphoma High-risk cancer

Contacts and locations

Locations

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.