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Golidocitinib for Mycosis Fungoides/Sezary Syndrome and Large Granular Lymphocytic Leukemia

(GEMSTONE Trial)

NM
Overseen ByNeha Mehta-Shah, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

NM

Neha Mehta-Shah, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with advanced mycosis fungoides, Sézary syndrome (types of skin lymphoma), or T-cell large granular lymphocytic leukemia who need treatment. Participants must be able to take oral medication and meet basic health requirements.

Inclusion Criteria

I am at least 18 years old.
I am able to care for myself and be active despite my MF/SS.
MF/SS: Patients must be able to swallow pills
See 15 more

Exclusion Criteria

I have not taken other trial drugs or treatments for T-LGLL in the past two weeks.
LGLL: Unstable or severe uncontrolled medical or psychiatric illness or abnormal labs increasing risk per investigator judgment
LGLL: Pregnant and/or breastfeeding
See 15 more

What Are the Treatments Tested in This Trial?

Interventions

  • Golidocitinib

Trial Overview

The study tests golidocitinib, taken by mouth once daily, as the only treatment in two groups: one with advanced MF/SS and another with T-LGLL. Up to 24 patients will participate in this open-label pilot study at a single center.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort 2: T-cell large granular lymphocytic leukemia (T-LGLL) - GolidocitinibExperimental Treatment1 Intervention
Group II: Cohort 1: Advanced-stage mycosis fungoides/Sézary syndrome (MF/SS) - GolidocitinibExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Dizal Pharmaceuticals

Industry Sponsor

Trials
27
Recruited
2,500+

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