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

RECRUITINGPhase 3Sponsored by Dizal Pharmaceuticals
Actively Recruiting
PhasePhase 3
SponsorDizal Pharmaceuticals
Started2024-05-13
Est. completion2027-11-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07234162

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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 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 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

Conditions2

CancerPeripheral T Cell Lymphoma

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