Trials / Recruiting
RecruitingNCT07234162
A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)
A Phase 3, Open-Label, Randomized, Multinational Study to Investigate the Anti-tumor Efficacy of Golidocitinib Versus Investigator's Choice in Adult Patients With Relapsed/Refractory Peripheral T-cell Lymphoma
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 218 (estimated)
- Sponsor
- Dizal Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 3, open-label, randomized, multinational study to evaluate the anti-tumor efficacy of golidocitinib versus investigator's choice in adult patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL). This study will treat patients with pathologically confirmed PTCL who have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen(s).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Golidocitinib | 150 mg, orally, once daily, with or without food, in a 21-day cycle |
| DRUG | Chidamide | 30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle |
| DRUG | Pralatrexate | 30 mg/m2, intravenous push, once weekly for 6 weeks in 7-week cycles |
| DRUG | Gemcitabine | 1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle |
| DRUG | Belinostat | 1000 mg/m2, intravenous infusion, administered once daily (QD) on Day 1 to Day 5 of a 21-day cycle |
Timeline
- Start date
- 2024-05-13
- Primary completion
- 2027-11-30
- Completion
- 2028-10-31
- First posted
- 2025-11-18
- Last updated
- 2025-11-18
Locations
50 sites across 3 countries: China, Taiwan, Thailand
Source: ClinicalTrials.gov record NCT07234162. Inclusion in this directory is not an endorsement.