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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
218
150 mg, orally, once daily, with or without food, in a 21-day cycle
30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle
30 mg/m2, intravenous push, once weekly for 6 weeks in 7-week cycles
Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to Lugano 2014
Time frame: The time from the date of randomization to the date of first progressive disease, death due to any cause whichever occurred first. Approximately 4 years.
Overall survival (OS)
Time frame: The time from randomization to death due to any cause. Approximately 4 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle
1000 mg/m2, intravenous infusion, administered once daily (QD) on Day 1 to Day 5 of a 21-day cycle
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
RECRUITINGThe Second Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGBeijing Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGGansu Provincial Cancer Hospital
Lanzhou, Gansu, China
RECRUITING...and 40 more locations