Clinical trial · Interventional
A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Golidocitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Golidocitinib
- interventionNames
- Drug: Golidocitinib
- type
- ACTIVE_COMPARATOR
- label
- Investigator's Choice
- interventionNames
- Drug: Chidamide
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available