Combination treatment for relapsed or refractory natural killer T-cell lymphoma
A Single-arm, Open-label, Phase II Study of Golidocitinib and Benmelstobart Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (ENKTL) (JACKPOT50)
This study is testing a new combination of two medications to see if they can help people with a type of lymphoma that hasn't responded to previous treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | golidocitinib |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06733051 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a combination treatment using golidocitinib and benmelstobart in patients with relapsed or refractory extranodal natural killer/T cell lymphoma. It is a prospective, single-arm, multicenter phase II trial that aims to determine how well these medications work together in this specific patient population. Participants must have previously failed at least one line of asparaginase-based therapy and meet other eligibility criteria. The study will assess treatment outcomes based on measurable lesions and overall patient health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed extranodal natural killer/T cell lymphoma who have experienced treatment failure with prior therapies.
Not a fit: Patients with invasive NK-cell leukemia, central nervous system involvement, or those who have previously been treated with JAK inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat forms of lymphoma.
How similar studies have performed: While this approach is novel in the context of this specific combination, similar studies have shown promise in treating other forms of lymphoma with targeted therapies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Beijing Tongren Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Qingqing Cai, MD. PhD.
- Email: caiqq@sysucc.org.cn
- Phone: 0086-20-87342823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.