New combo shows promise for rare blood cancer
NCT ID NCT07385989
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.
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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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2032
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 to 70 years
- 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: 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.
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 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.
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Other studies related to the condition(s) this trial covers.
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