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A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)

NCT07234162 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2025-11-18

No results posted yet for this study

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

  • Peripheral T-cell Lymphoma

Interventions

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

Sponsors & Collaborators

  • Dizal Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Zhao · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-13
Primary Completion
2027-11-30
Completion
2028-10-31

Countries

  • China
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07234162 on ClinicalTrials.gov