RecruitingPhase 3

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

China, Taiwan, Thailand218 participantsStarted 2024-05-13

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The participants should sign the ICF and be able to comply with the relevant requirements in the ICF and protocol * Age ≥ 18 years * ECOG 0-2 score, life expectancy ≥ 12 weeks * Patients must have histologically confirmed peripheral T-cell lymphoma according to the World Health Organization classiﬁcation of lymphoma. Eligible subtypes are restricted to: PTCL-not otherwise specified, NOS (PTCL, NOS), Angioimmunoblastic T-cell lymphoma (AITL), anaplastic large-cell lymphoma ALK-positive (ALCL ALK+), anaplastic large-cell lymphoma ALK-negative (ALCL ALK-), Follicular T-cell lymphoma, or PTCL with T-follicular helper (TFH) phenotype (FTCL or PTCL-TFH), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Natural killer/T-cell lymphoma (NK/TCL), Hepatosplenic T-cell lymphoma (HSTCL), Subcutaneous panniculitis-like T-cell lymphoma (SPTCL) * Progressed on, were refractory to or intolerant to at least one line of prior standard systemic therapies assessed by investigator * Adequate bone marrow reserve and organ system functions * Willing to comply with contraceptive restrictions Exclusion Criteria: * Any of previous or current treatment prohibited by protocol * Any unresolved \> grade 2 drug-related adverse events * Lymphoma involving central nervous system * Any of severe cardiac or pulmonary abnormalities * Disease condition requires immunosuppressants, biologics, or NSAIDs * Active infection * Malig…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing golidocitinib against an 'investigator's choice' treatment — what would you personally choose for me from that comparator arm, and how does it stack up against what golidocitinib is being tested for?
2Since this is a Phase 3 trial, what do we already know about golidocitinib's safety profile and effectiveness from earlier studies, and are there any risks I should be especially aware of given my specific situation?
3The trial is measuring how long I go without my lymphoma progressing — but how does that outcome relate to whether I might actually live longer or feel better, and is that something we'd be able to track during the study?
4This is a multinational trial that's currently enrolling — do you know if there's a participating site near me, and what would the time and travel commitment realistically look like for someone in my position?
5Given that my lymphoma has already come back or not responded to prior treatment, would you recommend trying a standard salvage therapy first before considering this trial, or does the timing of enrollment actually matter here?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to Lugano 2014

Timeframe: 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.

Trial details

NCT IDNCT07234162

SponsorDizal Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11-30

Contact for this trial

Ling Zhou

021-61095755 ling.zhou@dizalpharma.com

View on ClinicalTrials.gov More Peripheral T-cell Lymphoma trials