Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
NCT07682792 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-07-06
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.
Conditions
- Mycosis Fungoides/Sezary Syndrome
- T-cell Large Granular Lymphocytic Leukemia
Interventions
- DRUG
-
Golidocitinib
Golidocitinib is a JAK1 kinase inhibitor taken orally at a dose of 150mg.
Sponsors & Collaborators
-
Dizal Pharmaceuticals
collaborator INDUSTRY -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Neha Mehta-Shah, MD · Washington University School of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2030-01-31
- Completion
- 2032-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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