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

RecruitingPhase 3Ages 18 Years - anyAllDizal Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Golidocitinib
  • Chidamide
  • Gemcitabine
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Where

51 sites
Anhui Provincial Cancer Hospital
Hefei, China
The Second Hospital of Anhui Medical University
Hefei, China
Beijing Hospital
Beijing, China
Beijing Tongren Hospital, CMU
Beijing, China
Peking University Third Hospital
Beijing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Fujian Cancer Hospital
Fuzhou, China
The First Affiliated Hospital of Xiamen University
Xiamen, China

…and 43 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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