This is an open-label, single-institution pilot study of single-agent golidocitinib enrolling up to 24 patients in two cohorts: a) advanced-stage mycosis fungoides/Sézary syndrome (MF/SS), n=12, or b) T-cell large granular lymphocytic leukemia (T-LGLL) requiring treatment, n=12. Patients will receive single agent golidocitinib at the previously established dose of 150 mg QD as determined in the phase I and II studies of golidocitinib.
Histologically or cytologically confirmed mycosis fungoides or Sézary syndrome, stages IB to IVB with measurable disease and/or detectable blood involvement based on the Global Response Criteria for CTCL
Received at least one prior line of systemic therapy.
At least 18 years of age.
ECOG performance status ≤ 2
Patients with active CNS lymphoma.
A history of other malignancy, with the exception of prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Currently receiving any other investigational agents.
At least 8 weeks for low-dose (12 Gy or less) total skin electron beam therapy (TSEBT).
Washington University School of Medicine
Lead sponsor
Dizal Pharmaceuticals
Collaborator