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.
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
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.
At least 8 weeks for low-dose (12 Gy or less) total skin electron beam therapy (TSEBT).
Parallel
Golidocitinib
DrugGolidocitinib is a JAK1 kinase inhibitor taken orally at a dose of 150mg.
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 E5998 prospective clinical trial for T-LGLL.
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 E5998 prospective clinical trial (NCT03239392) for T-LGLL
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 E5998 prospective clinical trial (NCT03239392) for T-LGLL.
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 E5998 prospective clinical trial (NCT03239392) for T-LGLL.
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 E5998 prospective clinical trial (NCT03239392) for T-LGLL.
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Washington University School of Medicine
Lead sponsor
Dizal Pharmaceuticals
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
