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Recruiting NCT07234162

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

Phase III Interventional Peripheral T-cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Golidocitinib, Chidamide, Gemcitabine.
Who it may be relevant to
Registry conditions: Peripheral T-cell Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China, Taiwan, Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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).

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

Primary outcome measures

  • 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 outcome measures (1)
  • Overall survival (OS) [Time frame: The time from randomization to death due to any cause. Approximately 4 years.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 36 centers
  • Anhui Provincial Cancer Hospital — Hefei
  • The Second Hospital of Anhui Medical University — Hefei
  • Beijing Hospital — Beijing
  • Beijing Tongren Hospital, CMU — Beijing
  • Peking University Third Hospital — Beijing
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing
  • Fujian Cancer Hospital — Fuzhou
  • The First Affiliated Hospital of Xiamen University — Xiamen
  • … and 28 more centers
Taiwan · 8 centers
  • Chang Bing Show Chwan Memorial Hospital — Changhua
  • Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City
  • Taipei Medical University - Shuang Ho Hospital — New Taipei City
  • China Medical University Hospital — Taichung
  • Chi Mei Medical Center - Liouying Branch — Tainan
  • National Cheng Kung University Hospital — Tainan
  • National Taiwan University Hospital — Taipei
  • Koo Foundation Sun Yat-Sen Cancer Center — Taipei
Thailand · 7 centers
  • King Chulalongkorn Memorial Hospital — Bangkok
  • Mahidol University - Faculty of Medicine - Ramathibodi Hospital — Bangkok
  • Phramongkutklao Hospital — Bangkok
  • Siriraj Hospital - Mahidol University — Bangkok
  • Maharaj Nakorn Chiang Mai Hospital — Chiang Mai
  • Prince of Songkla University-Faculty of Medicine — Hat Yai
  • Srinagarind Hospital - Faculty of Medicine Khon Kaen University — Khon Kaen

Identifiers

NCT: NCT07234162 · DZ2022J0004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗