NCT06733051 Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)
| NCT ID | NCT06733051 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Natural Killer T-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 47 participants |
| Start Date | 2024-01-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 47 participants in total. It began in 2024-01-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of golidocitinib and benmelstobart combination treatment in patients with relapsed or refractory extranodal natural killer/T cell lymphoma.
Eligibility Criteria
Inclusion Criteria: 1. Subjects fully understand and voluntarily participate in this study and sign informed consent. 2. Pathologically confirmed extranodal natural killer/T cell lymphoma (ENKTL). 3. Age ≥18, no gender limitation. 4. Treatment failure to at least one line of asparaginase-based therapy. 5. Eastern Cooperative Oncology Group performance status of 0-2 6. Expected survival ≥ 3 months. 7. At least one measurable lesion that meets Lugano 2014 criteria. 8. Sufficient organ function. Exclusion Criteria: 1. Invasive NK-cell leukemia or NKTCL that has progressed to leukemia. 2. Accompanied by hemophagocytic lymphohistiocytosis. 3. NKTCL with central nervous system invasion. 4. Previously treated with JAK inhibitors. 5. The patients have contraindications to any drug in the combined treatment. 6. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome. 7. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug. 8. Pregnant and lactating women and subjects of childbearing age who do not want to use contraception. 9. Mentally ill persons or persons unable to obtain informed consent. The investigators think that the patient is not suitable for the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06733051 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Natural Killer T-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06733051 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06733051 currently recruiting?
Yes, NCT06733051 is actively recruiting participants. Contact the research team at caiqq@sysucc.org.cn for enrollment information.
Where is the NCT06733051 trial being conducted?
This trial is being conducted at Beijing, China, Guangzhou, China.
Who is sponsoring the NCT06733051 clinical trial?
NCT06733051 is sponsored by Sun Yat-sen University. The trial plans to enroll 47 participants.