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

ConditionPeripheral T-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Golidocitinib

    Drug

    150 mg, orally, once daily, with or without food, in a 21-day cycle

  • Chidamide

    Drug

    30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle

  • Gemcitabine

    Drug

    1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle

Treatment groups

218 Participants
are divided into 2 treatment groups
Group A: GolidocitinibExperimental treatment 1 intervention
Group B: Investigator's ChoiceActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

Overall survival (OS)

Time frame
The time from randomization to death due to any cause. Approximately 4 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dizal Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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