Golidocitinib for Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
This study is testing golidocitinib, an oral medication, in people with Mycosis Fungoides/Sézary Syndrome (a type of skin lymphoma) or T-cell Large Granular Lymphocytic Leukemia (a rare blood cancer). Golidocitinib works by targeting a protein called JAK1. The study aims to see how many patients respond to golidocitinib treatment. You may be able to join if you are at least 18 years old, have advanced Mycosis Fungoides/Sézary Syndrome with measurable disease and have already received at least one other treatment. The study plans to enroll up to 24 patients. The current recruitment status is unclear.
- Study design
- This is an open-label study, meaning both you and your doctors will know you are receiving golidocitinib. It is a pilot study conducted at a single institution and plans to enroll up to 24 participants.
- What's involved
- You will take golidocitinib orally at a dose of 150mg once daily. The study will measure your response to treatment at four months after you start taking the medication.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at four months after the start of treatment. Further follow-up details are not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07682792
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~24 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Golidocitinib
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR)
Measured over At four months after start of treatment
Conditions
NCT07682792
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Washington University School of Medicine
St Louis, Missouristudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Neha Mehta-Shah, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Eligibility criteria
Inclusion
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:
Serum Creatinine ≤ 2 x IULN
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using the Modification of Diet in Renal Disease (MDRD) equation (multiplying eGFR by each subject's Body Surface Area \[BSA\])
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.
Patients must be 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).
Untreated T-LGLL or failed at least one line of frontline therapy.
Patients must 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:
Serum Creatinine ≤ 2 x IULN
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using the Modification of Diet in Renal Disease (MDRD) equation (multiplying eGFR by each subject's Body Surface Area \[BSA\])
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.
Patients must be 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.
Exclusion
Patients with 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.
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.
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.
Pregnant and/or breastfeeding.
Concurrent immune-suppressive therapy exceeding prednisone 20 mg equivalent.
Patients with 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.
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.
Pregnant and/or breastfeeding.
What this trial measures
- Overall Response Rate (ORR)At four months after start of treatment
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 E5998 prospective clinical trial for T-LGLL.