RecruitingPhase 2NCT06733051
Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)
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)
Sponsor
Sun Yat-sen University
Enrollment
47 participants
Start Date
Jan 27, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria8
- Subjects fully understand and voluntarily participate in this study and sign informed consent.
- Pathologically confirmed extranodal natural killer/T cell lymphoma (ENKTL).
- Age ≥18, no gender limitation.
- Treatment failure to at least one line of asparaginase-based therapy.
- Eastern Cooperative Oncology Group performance status of 0-2
- Expected survival ≥ 3 months.
- At least one measurable lesion that meets Lugano 2014 criteria.
- Sufficient organ function.
Exclusion Criteria9
- Invasive NK-cell leukemia or NKTCL that has progressed to leukemia.
- Accompanied by hemophagocytic lymphohistiocytosis.
- NKTCL with central nervous system invasion.
- Previously treated with JAK inhibitors.
- The patients have contraindications to any drug in the combined treatment.
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
- Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
- Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
- Mentally ill persons or persons unable to obtain informed consent. The investigators think that the patient is not suitable for the study.
Interventions
DRUGGolidocitinib
150 mg, administered once daily from Day 1 to Day 21 (D1-D21)
DRUGBenmelstobart
1200 mg, administered on Day 1 (D1) of every cycle
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06733051
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