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New combo shows promise for rare blood cancer

NCT ID NCT07385989

Disease control Sponsor: WEI XU Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the drug golidocitinib to standard chemotherapy and immunotherapy works better than the standard treatment alone for people with advanced NK/T-cell lymphoma, a rare blood cancer. About 40 adults will be randomly assigned to one of two groups. The main goal is to see if the new combo leads to more complete remissions after 6 cycles of treatment.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

An estimate. End dates often move.

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: 1. Voluntarily provides written informed consent (ICF) prior to any study procedures. 2. Aged 18-70 years (inclusive), regardless of sex. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histologically confirmed extranodal NK/T-cell lymphoma (ENKTL), staged as Stage III-IV or non-nasal ENKTL (per 2016 WHO Classification of Hematopoietic and Lymphoid Tumors). 5. At least one measurable/evaluable lesion (per 2014 Lugano Classification: measurable lesion ≥1.5 cm in longest diameter + ≥1.0 cm in shortest diameter; evaluable lesion with FDG uptake higher than liver on PET/CT). 6. Treatment-naive (no prior anti-cancer therapy for ENKTL). 7. Adequate organ function: AST/ALT ≤2.5×upper limit of normal (ULN); Total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine \<1.5×ULN or creatinine clearance (CrCl, via Cockcroft-Gault formula) ≥60 mL/min. 8. Reproductive-aged females have a negative pregnancy test at screening; all participants use effective contraception during the study and for 12 months after the last dose. 9. Expected survival ≥6 months. Exclusion Criteria: 1. Complicated by hemophagocytic lymphohistiocytosis (HLH) or aggressive NK-cell leukemia. 2. Contraindication to golidocitinib, PD-1 inhibitor, or any component of the P-GEMOX regimen. 3. Lymphoma involvement of the central nervous system (CNS). 4. Major surgery (excluding diagnostic biopsy) within 4 weeks prior to study treatment initiation. 5. History of other malignant tumors (except curatively treated in situ cancers, e.g., cervical carcinoma in situ) within 5 years. 6. Uncontrolled severe comorbidities (e.g., NYHA Class II+ heart failure, unstable angina, myocardial infarction within 1 year, uncontrolled arrhythmias). 7. Active bleeding (e.g., gastrointestinal hemorrhage, cerebral hemorrhage). 8. Uncontrolled infection (requiring parenteral anti-infective therapy) within 7 days prior to study treatment. 9. Active hepatitis B/C: HBsAg+/HBcAb+ with HBV-DNA \>2500 copies/mL (or 500 IU/mL); HCV antibody+ with positive HCV-RNA. 10. HIV infection or acquired immunodeficiency syndrome (AIDS). 11. Conditions impairing drug absorption (e.g., inability to swallow tablets, malabsorption syndrome). 12. Pregnant/lactating females, or reproductive-aged participants refusing contraception. 13. Psychiatric illness precluding informed consent or study compliance. 14. Other conditions deemed unsuitable for enrollment by the investigator.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

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