Clinical Trials Directory

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

TypeNameDescription
DRUGGolidocitinib150 mg, orally, once daily, with or without food, in a 21-day cycle
DRUGChidamide30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle
DRUGPralatrexate30 mg/m2, intravenous push, once weekly for 6 weeks in 7-week cycles
DRUGGemcitabine1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle
DRUGBelinostat1000 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.