Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07682792
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Mycosis Fungoides/Sezary Syndrome
  • T-cell Large Granular Lymphocytic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Golidocitinib — DRUG
    Golidocitinib is a JAK1 kinase inhibitor taken orally at a dose of 150mg.

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2030
Completion
Sep 30, 2032

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Advanced-stage mycosis fungoides/Sézary syndrome (MF/SS) - Golidocitinib
    Patients with advanced-stage MF/SS will take golidocitinib as a 150 mg pill orally each day of a 28-day cycle.
  • Experimental: Cohort 2: T-cell large granular lymphocytic leukemia (T-LGLL) - Golidocitinib
    Patients with T-LGLL will take golidocitinib as a 150 mg pill orally each day of a 28-day cycle.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: At four months after start of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Neha Mehta-Shah, MD
[email protected]
557-747-2108
Neha Mehta-Shah, MD (PRINCIPAL_INVESTIGATOR)
Hunter C Cochran, MD (SUB_INVESTIGATOR)
Todd Fehniger, MD, PhD (SUB_INVESTIGATOR)
Jacqueline Payton, MD, PhD (SUB_INVESTIGATOR)
Fei Wan, PhD (SUB_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MO

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