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Mycosis Fungoides/Sezary SyndromePhase 2GEMSTONENCT07682792

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

A Phase 2 study testing Golidocitinib in people with Mycosis Fungoides/Sezary Syndrome and T-cell Large Granular Lymphocytic Leukemia, run by Washington University School of Medicine at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Golidocitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
31 Dec 2026to 31 Dec 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 (Olsen et al., 2022).
  • Received at least one prior line of systemic therapy.
  • Requires systemic therapy for their CTCL, in the opinion of the treating physician.
  • At least 18 years of age.
  • ECOG performance status ≤ 2
  • Adequate counts and organ function as defined below:
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  • 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 platelet count remains at the above threshold without transfusion for 5 days.
  • Estimated (as calculated by the Cockcroft-Gault method) or measured creatinine clearance ≥ 30 mL/min.
  • Serum total bilirubin ≤ 1.5 x IULN if no liver involvement, or ≤ 2 x IULN in the presence of Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver involvement.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x IULN, or ≤ 5 x IULN if documented hepatic involvement with lymphoma.
  • Able to swallow pills.
  • The effects of golidocitinib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use highly effective methods of contraception for the duration of study participation and for 3 months after the last dose of golidocitinib for female patients and female partners of male patients, or for 6 months after the last dose of golidocitinib for male patients and male partners of female patients. Should a woman become pregnant or suspect she is pregnant or a male patient suspect he has impregnated another while participating in this study, s/he must inform the treating physician immediately.
  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
  • Diagnosis of T-LGLL defined as: CD3+CD8+ cell population > 650/mm3 or CD3+CD8+CD57+ population > 500/mm3 and the presence of a clonal T-cell receptor (within 1 month of diagnosis).
  • Note: patients with MDS-like T-LGLL may be included with PI approval even if CD3+CD8+ cell population is < 650/mm3, though +TCR is required. Natural-Killer (NK) LGL is also permitted, provided there is a clonal NK-cell population noted with > 500 cells/mm3.
  • Had at least one line of systemic therapy for T-LGLL.
  • Require treatment for T-LGLL, as defined by meeting one or more of the below criteria:
  • Symptomatic anemia with hemoglobin < 10 g/dL
  • Transfusion-dependent anemia
  • Neutropenia with absolute neutrophil count (ANC) < 0.5 K/cumm
  • Neutropenia with ANC < 1.5 K/cumm with recurrent infections
  • At least 18 years of age.
  • ECOG performance status ≤ 2
  • Adequate counts and organ function as defined below:
  • Platelet count > 50 K/cumm. Platelet transfusion may be utilized to meet inclusion criteria, as long as the platelet count remains > 50 K/cumm within 5 days of last transfusion.
  • Estimated (as calculated by the Cockcroft-Gault method) or measured creatinine clearance ≥ 30 mL/min.
  • Serum total bilirubin ≤ 1.5 x IULN if no liver involvement, or ≤ 2 x IULN in the presence of Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver involvement.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x IULN, or ≤ 5 x IULN if documented hepatic involvement with T-LGLL.
  • Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression.
  • Able to swallow pills.
  • The effects of golidocitinib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use highly effective methods of contraception for the duration of study participation and for 3 months after the last dose of golidocitinib for female patients and female partners of male patients, or for 6 months after the last dose of golidocitinib for male patients and male partners of female patients. Should a woman become pregnant or suspect she is pregnant or a male patient suspect he has impregnated another while participating in this study, s/he must inform the treating physician immediately.
  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Who cannot join

  • 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.
  • Concomitant use of another systemic therapy for MF/SS. Patients must have the following minimum washout from previous treatments:
  • At least 8 weeks for low-dose (12 Gy or less) total skin electron beam therapy (TSEBT).
  • At least 4 weeks for systemic cytotoxic anticancer agents or for tumor-targeting monoclonal antibodies (mAbs), with the exception of alemtuzumab, for which the washout is at least 16 weeks.
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  • At least 2 weeks or 5 half-lives (whichever is shorter) for systemic retinoids, interferons, vorinostat, romidepsin, and denileukin diftitox, or anticancer investigational agents that are not defined as immunotherapy.
  • At least 1 week for topical retinoids, nitrogen mustard, or imiquimod.
  • Receipt of medications or herbal supplements known to be strong inhibitors of CYP3A4 within the following time frames prior to the first dose of golidocitinib:
  • 7 days for Ketoconazole, itraconazole, indinavir, saquinovir, nelfinavir, atazanavir, amprenavir, fosamprenavir, troleandomycin, telithromycin, fluconazole, nefazodone, cimetidine, aprepitant, miconazole, fluvoxamine
  • 14 days for Erythromycin, clarithromycin, verapamil, ritonavir, diltiazem
  • 6 weeks for amiodarone
  • Receipt of medications known to prolong the QT interval within the following time frames:
  • 2 days for clarithromycin, droperidol, erythromycin, procainamide
  • 14 days for Cisapride, disopyramide, dofetilide, domperidone, ibutilide, quinidine, sotalol, sparfloxacin, thioridazine
  • 4 weeks for levomethadyl, methadone, pimozide
  • 6 weeks for arsenic trioxide
  • 8 weeks for pentamidine
  • 52 weeks for chloroquine
  • Gastrointestinal disorders, or any other condition that may significantly interfere with absorption of the study medication by the investigator's assessment.
  • Uncontrolled active infection requiring IV antibiotic, antiviral, or antifungal medications within 14 days before the first dose of study drug. Infections (e.g., urinary tract infection) controlled on concurrent antimicrobial agents and antimicrobial prophylaxis per institutional guidelines are acceptable.
  • Current known active or chronic infection with HIV, hepatitis B, or hepatitis C. All patients will require serologic testing to be performed within 6 months prior to C1D1.
  • Patients with chronic HBV are defined as patients with positive hepatitis B serology: Patients with a negative HBsAg and a positive HBcAb require an undetectable/negative hepatitis B DNA test (e.g. polymerase chain reaction [PCR] test) to be enrolled and will require prophylactic antiviral treatment initiated prior to the first dose of study drug, and continued until approximately 6 to 12 months after completion of study drug(s).
  • Patients with chronic HCV infection are defined as patients with a positive hepatitis C antibody (anti-HCV) test:
  • Patients with a positive anti-HCV antibody test require a quantitative HCV RNA viral load test (e.g., polymerase chain reaction [PCR] test) to determine eligibility. Patients with a positive anti-HCV antibody and a detectable/positive HCV RNA (i.e., active chronic HCV infection) are not eligible.
  • Patients with a positive anti-HCV antibody and an undetectable/negative HCV RNA (i.e., prior resolved infection or previously treated and cured HCV) are eligible for enrollment without antiviral treatment.
  • Unstable or severe uncontrolled medical condition or any important medical or psychiatric illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the patient associated with his/her participation in this study.
  • QTcF ≥ 480 msec.
  • Pregnant and/or breastfeeding.
  • Concurrent immune-suppressive therapy exceeding prednisone 20 mg equivalent.
  • Active CNS involvement with T-LGLL.
  • 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, or receipt of another systemic therapy for T-LGLL within 14 days or 5 half-lives of the first dose of golidocitinib, whichever is shorter.
  • Receipt of medications or herbal supplements known to be strong inhibitors or inducers of CYP3A4 within the following time frames prior to the first dose of golidocitinib:
  • 7 days for Ketoconazole, itraconazole, indinavir, saquinovir, nelfinavir, atazanavir, amprenavir, fosamprenavir, troleandomycin, telithromycin, fluconazole, nefazodone, cimetidine, aprepitant, miconazole, fluvoxamine
  • 14 days for Erythromycin, clarithromycin, verapamil, ritonavir, diltiazem
  • 6 weeks for amiodarone
  • Receipt of medications known to prolong the QT interval within the following time frames:
  • 2 days for clarithromycin, droperidol, erythromycin, procainamide
  • 14 days for Cisapride, disopyramide, dofetilide, domperidone, ibutilide, quinidine, sotalol, sparfloxacin, thioridazine
  • 4 weeks for levomethadyl, methadone, pimozide
  • 6 weeks for arsenic trioxide
  • 8 weeks for pentamidine
  • 52 weeks for chloroquine
  • Gastrointestinal disorders, or any other condition that may significantly interfere with absorption of the study medication by the investigator's assessment.
  • Uncontrolled active infection requiring IV antibiotic, antiviral, or antifungal medications within 14 days before the first dose of study drug. Infections (e.g., urinary tract infection) controlled on concurrent antimicrobial agents and antimicrobial prophylaxis per institutional guidelines are acceptable.
  • Current known active or chronic infection with HIV, hepatitis B, or hepatitis C. All patients will require serologic testing to be performed within 6 months prior to C1D1.
  • Patients with chronic HBV are defined as patients with positive hepatitis B serology: Patients with a negative HBsAg and a positive HBcAb require an undetectable/negative hepatitis B DNA test (e.g. polymerase chain reaction [PCR] test) to be enrolled and will require prophylactic antiviral treatment initiated prior to the first dose of study drug, and continued until approximately 6 to 12 months after completion of study drug(s).
  • Patients with chronic HCV infection are defined as patients with a positive hepatitis C antibody (anti-HCV) test: Patients with a positive anti-HCV antibody test require a quantitative HCV RNA viral load test (e.g., polymerase chain reaction [PCR] test) to determine eligibility. Patients with a positive anti-HCV antibody and a detectable/positive HCV RNA (i.e., active chronic HCV infection) are not eligible. AND Patients with a positive anti-HCV antibody and an undetectable/negative HCV RNA (i.e., prior resolved infection or previously treated and cured HCV) are eligible for enrollment without antiviral treatment.
  • Unstable or severe uncontrolled medical condition or any important medical or psychiatric illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the patient associated with his/her participation in this study.
  • QTcF ≥ 480 msec.
  • Pregnant and/or breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Neha Mehta-Shah, MD contact

557-747-2108

mehta-n@wustl.edu

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Neha Mehta-Shah, MD, 557-747-2108, mehta-n@wustl.edu

    Neha Mehta-Shah, MD

Other trials in United States

About this study

Official title: A Pilot Study of Golidocitinib, a JAK1 Inhibitor, in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia (GEMSTONE)

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.

Being tested
Golidocitinib
Keywords
JAK inhibitor, Golidocitinib, Cutaneous T-cell lymphoma
Medical subject headings
Mycosis Fungoides, Sezary Syndrome, Leukemia, Large Granular Lymphocytic, Lymphoma, T-Cell, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GolidocitinibDrug

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

Study groups in NCT07682792
Study groupRoleWhat they receive
Cohort 1: Advanced-stage mycosis fungoides/Sézary syndrome (MF/SS) - GolidocitinibExperimentalPatients with advanced-stage MF/SS will take golidocitinib as a 150 mg pill orally each day of a 28-day cycle.
Receives: Drug: Golidocitinib
Cohort 2: T-cell large granular lymphocytic leukemia (T-LGLL) - GolidocitinibExperimentalPatients with T-LGLL will take golidocitinib as a 150 mg pill orally each day of a 28-day cycle.
Receives: Drug: Golidocitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    ORR is defined as the proportion of evaluable patients achieving complete response (CR) or partial response (PR). As assessed according to the Global Response Criteria for CTCL and and International Consensus Criteria for T-LGLL.

    Measured: At four months after start of treatment

Secondary outcomes (7)

  1. Best overall response rate

    Best overall response rate is defined by the best response of a given patient while being evaluated on study as assessed according to the Global Response Criteria for CTCL and and International Consensus Criteria for T-LGLL.

    Measured: Through completion of treatment (estimated to be 12 months)

  2. Complete response rate

    Complete response rate is defined as the percentage of patients treated achieving a complete response (CR) as assessed according to the Global Response Criteria for CTCL and and International Consensus Criteria for T-LGLL.

    Measured: Through completion of treatment (estimated to be 12 months)

  3. Duration of response

    Duration of response is defined as the time from first initial response to progression of disease as assessed according to the Global Response Criteria for CTCL and and International Consensus Criteria for T-LGLL.

    Measured: From date of first response through disease progression (estimated to be 22 months)

  4. Time to maximum response

    Time to maximum response is defined by the time from initiation of study therapy to the time to achieve the best response as assessed according to the Global Response Criteria for CTCL and and International Consensus Criteria for T-LGLL.

    Measured: Through completion of treatment (estimated to be 12 months)

  5. Clinical benefit rate

    Clinical benefit rate is defined by the percentage of patients treated who have achieved a complete response (CR), partial response (PR) or have stable disease (SD) for 6 months or greater as assessed according to the Global Response Criteria for CTCL and and International Consensus Criteria for T-LGLL.

    Measured: Through completion of treatment (estimated to be 12 months)

  6. Frequency and grades of treatment-emergent adverse events (TEAE)

    As assessed by CTCAE v6.0

    Measured: From start of treatment through start of new treatment or 30 days after completion of treatment, whichever is earlier (estimated to be 13 months)

  7. Rate of treatment discontinuation due to TEAE

    As assessed by CTCAE v6.0

    Measured: Through completion of treatment (estimated to be 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study start31 Dec 2026 (estimated)
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07682792
Sponsor's protocol ID
202609148
Acronym
GEMSTONE
Status last verified
Nov 2026
First submitted
26 Jun 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Golidocitinib in people with Mycosis Fungoides/Sezary Syndrome and T-cell Large Granular Lymphocytic Leukemia, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Neha Mehta-Shah, MD (557-747-2108, mehta-n@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: At four months after start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07682792.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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