A Pilot Study of Golidocitinib, a JAK1 Inhibitor, in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia (GEMSTONE)
Washington University School of Medicine
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria for MF/SS: * 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 * Adequate counts and organ function as defined below: * Platelet count \> 75 K/cumm, unless related to lymphoma, in which case platelet count must be \> 50 K/cumm. Platelet transfusion may be utilized to meet inclusion criteria, as long as the p…
Interventions
- DrugGolidocitinib
Golidocitinib is a JAK1 kinase inhibitor taken orally at a dose of 150mg.
Location
- Washington University School of MedicineSt Louis, Missouri