Phase I Study With an Expansion Cohort of Tulmimetostat (CPI-0209) in Patients With Mycosis Fungoides and Sézary Syndrome
The hypotheses of this study are that single agent CPI-0209 will be safe and well tolerated in patients with advanced (stage IB-IVB) mycosis fungoides (MF)/Sézary syndrome (SS) who have had at least one prior systemic therapy, and that in these patients, CPI-0209 will demonstrate efficacy and be worth of further study.
NCT05944562 — Mycosis Fungoides
Status: Recruiting
http://inclinicaltrials.com/mycosis-fungoides/NCT05944562/
Open Label, Single-cohort, and Single-center Phase II Study Evaluating Tumor-specific Immunity After Extracorporeal Photopheresis in Patients With Sézary Syndrome at Single-cell Resolution
The primary endpoint is to determine if ECP induces a decrease in % of tumor cells after treatment. 15 patients with Sezary Syndrome will receive ECP weekly x4, then bi-weekly for 5 months. Each patient will donate 5 samples to determine immune responses in peripheral blood. Additional clinical assessments will be a modified skin weighted assessment and flow cytometry at baseline and months 3 and 6. A CT scan will be obtained at baseline and only repeated if pathology is present at baseline. The tumor microenvironment will be studied by comparing transcriptomics of the blood samples before, 1 day after first ECP treatment, cycle 1, 1, 3 and 6 months after ECP treatment by scRNAseq (5 samples total per patient ).
NCT05157581 — Sezary Syndrome
Status: Recruiting
http://inclinicaltrials.com/sezary-syndrome/NCT05157581/
Pembrolizumab in Combination With Gemcitabine for Previously Treated Mycosis Fungoides and Sézary Syndrome: Efficacy and Characterization of Immune Response
The purpose of this study is to find out whether the combination of pembrolizumab and gemcitabine is an effective treatment for mycosis fungoides and Sézary syndrome.
NCT04960618 — Mycosis Fungoides
Status: Recruiting
http://inclinicaltrials.com/mycosis-fungoides/NCT04960618/
Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.
A translational study for identification of prognostic and treatment-predictive biomarkers in Mycosis fungoides and Sézary syndrome.
NCT04904146 — Mycosis Fungoides
Status: Recruiting
http://inclinicaltrials.com/mycosis-fungoides/NCT04904146/
Mogamulizumab and Extracorporeal Photopheresis (ECP) for the Treatment of Sézary Syndrome and Erythrodermic Mycosis Fungoides, a Phase 1b/2 Study
This phase Ib/II trial investigates the side effects of mogamulizumab and extracorporeal photopheresis and to see how well they work in treating patients with Sezary syndrome or mycosis fungoides. Mogamulizumab (a humanized antibody) binds to CCR4, a protein often found in high amounts on T-cell lymphoma cells. Binding to these cells may slow their growth, as well as mark them for attack by the immune system. Extracorporeal photopheresis (ECP) is a standard treatment for cancers that affects the skin, and may work by killing some lymphoma cells directly and by boosting the body's immune response against other lymphoma cells. Giving mogamulizumab together with ECP may work better in treating patients with Sezary syndrome or mycosis fungoides compared to either therapy alone.
NCT04676087 — Mycosis Fungoides
Status: Recruiting
http://inclinicaltrials.com/mycosis-fungoides/NCT04676087/
A Phase I Study With an Expansion Cohort of Duvelisib and Nivolumab in Mycosis Fungoides (MF) and Sézary Syndrome (SS)
This phase I trial identifies the best dose, possible benefits, and/or side effects of duvelisib in combination with nivolumab in treating patients with stage IIB-IVB mycosis fungoides and Sezary syndrome. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving duvelisib in combination with nivolumab may work better than giving each of these drugs individually, or treating with the usual approach in patients with mycosis fungoides and Sezary syndrome.
NCT04652960 — Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8
Status: Recruiting
http://inclinicaltrials.com/stage-iib-mycosis-fungoides-and-sezary-syndrome-ajcc-v8/NCT04652960/
A Phase 2 Single Center, Single Arm, Open Label Mogamulizumab Combined Upfront With Low Dose Total Skin Electron Beam Therapy (LD TSEBT) in Patients With Mycosis Fungoides (MF) and Sézary Syndrome (SS)
The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.
NCT04256018 — Mycosis Fungoides
Status: Recruiting
http://inclinicaltrials.com/mycosis-fungoides/NCT04256018/
Phase I Trial of Pembrolizumab and Total Skin Electron Beam Radiotherapy in Mycosis Fungoides and Sézary Syndrome
Hypothesis: Addition of low dose TSEBT to debulk MF/SS either before or during checkpoint blockade with anti-PD-1 pembrolizumab monoclonal antibody therapy will be safe and well tolerated. Primary Objective: • To determine the maximum tolerated dose (MTD) for the combination of total skin electron beam therapy (TSEBT) and pembrolizumab regimen. Secondary Objectives: - To determine the preliminary efficacy of the combination of TSEBT with pembrolizumab. - To determine the impact on patient-reported health-related quality of life outcomes.
NCT03617224 — Cutaneous T-Cell Lymphomas
Status: Withdrawn
http://inclinicaltrials.com/cutaneous-t-cell-lymphomas/NCT03617224/
Optimizing Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis
The purpose of this study is to test any good and bad effects of the study drug called brentuximab vedotin at a lower dose than is FDA-approved.
NCT03587844 — Mycosis Fungoides
Status: Recruiting
http://inclinicaltrials.com/mycosis-fungoides/NCT03587844/
A Multicentre, Double Blind, Randomised, Placebo-controlled, Phase II Trial to Evaluate Resminostat for Maintenance Treatment of Patients With Advanced Stage (Stage IIB-IVB) Mycosis Fungoides (MF) or Sézary Syndrome (SS) That Have Achieved Disease Control With Systemic Therapy - the RESMAIN Study
The purpose of this study is to determine whether resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary Syndrome that have recently achieved disease control with previous systemic therapy.
NCT02953301 — Mycosis Fungoides
Status: Active, not recruiting
http://inclinicaltrials.com/mycosis-fungoides/NCT02953301/