Assessing An Oral JAK1 Inhibitor, Golidocitinib, in Patients Who Have Newly Diagnosed Peripheral … (NCT07032532) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Assessing An Oral JAK1 Inhibitor, Golidocitinib, in Patients Who Have Newly Diagnosed Peripheral T-Cell Lymphoma (JACKPOT23)
China35 participantsStarted 2025-07
Plain-language summary
This study will treat patients with newly diagnosed PTCL, who have no prior systemic treatment for T-cell lymphoma. This study will assess the anti-tumor efficacy of golidocitinib using 2-year Progression-Free Survival rate as primary endpoint. In addition, it will help to understand what type of side effects may occur with the drug treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male and female ≥ 18 years old.
✓. ECOG performance status 0-2 with no deterioration over the previous 2 weeks.
✓. Predicted life expectancy ≥ 12 weeks.
✓. Patients must have histologically confirmed peripheral T-cell lymphoma. Eligible histological subtypes are restricted to the following:
✓. Patients must have measurable disease according to the 2014 Lugano classification.
✓. Patients must be treatment naïve with no prior systemic treatment for T-cell lymphoma.
✓. Adequate bone marrow reserve and organ system functions.
✓. Willing to comply with contraceptive restrictions.
Exclusion criteria
✕. Intervention with any of the following:
✕. Major surgery procedure, or significant traumatic injury within 4 weeks.
✕. Prior treatment with a JAK or STAT3 inhibitor.
✕. Prior treatment with any onco-immunotherapy in 28 days.
✕. Live vaccines within 28 days.
✕. Patients currently receiving (or unable to stop use at least 14 days prior to receiving the first dose) medications or herbal supplements known to be Potent inhibitors or inducers of CYP3A.
✕. Central nervous system or leptomeningeal lymphoma.
✕. Past medical history of pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.