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NCT Number: NCT07234162

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

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).

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Key information

Conditions

Peripheral T-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anhui Provincial Cancer Hospital, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Malignancy disease within five years
  • Poorly controlled gastrointestinal disorder or inadequate absorption of medication
  • Severe or poorly controlled systemic diseases

Treatment and study plan

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ling Zhou

CONTACT

[email protected]

021-61095755

Sponsors and collaborators

Lead sponsor

Dizal Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Nov 18, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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