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
Dizal Pharmaceuticals
218 participants
May 13, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria7
- The participants should sign the ICF and be able to comply with the relevant requirement 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 Criteria9
- Any of previous or current treatment prohibited by protocol
- Any unresolved \> grade 2 drug-related adverse events
- Lymphoma involving central nervous system
- Any of serere cardiac or pulmonary abnormalities
- Disease condition requiring 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
Interventions
150 mg, orally, once daily, with or without food, in a 21-day cycle
30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle
30 mg/m2, intravenous push, once weekly for 6 weeks in 7-week cycles
1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle
1000 mg/m2, intravenous infusion, administered once daily (QD) on Day 1 to Day 5 of a 21-day cycle
Locations(50)
View Full Details on ClinicalTrials.gov
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NCT07234162