This is an open label, multi-cohort, and multi-center phase II study, which evaluates the clinical activity and safety of IPH4102 in Sezary Syndrome and Mycosis fungoides as single agent.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Patients will receive a flat dose of 750mg
Objective Response Rate (ORR)
Using the Olsen (2011, JCO) criteria (All cohorts)
Time frame: From the first dose until study completion, an expected average of 2 years
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (All cohorts)
patients with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From first dose until study completion, an expected average of 2 years
Quality of life (QoL) (All cohorts)
Using the Skindex29 questionnaire to assesse the effects of skin disease on quality of life in three domains: Symptoms, Emotions, and Functioning
Time frame: Through study completion, an expected average of 2 years
pruritus (All cohorts)
Using Visual Analog Scale (VAS) for prutitus assessment: From 0 = No pruritus to 10 = Pruritus as bad as it could possibly be
Time frame: Through study completion, an expected average of 2 years
ORR using blinded central review (Cohort 1)
Using the Olsen (2011, JCO) criteria
Time frame: From the first dose until study completion, an expected average of 2 years
Progression free survival (PFS) (All cohorts)
Time frame: From the first dose until study completion, an expected average of 2 years
Overall survival (OS) (All cohorts)
Time frame: From the first dose until study completion, an expected average of 2 years
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, United States
Irvine Medical Center
Orange, California, United States
Stanford University
Stanford, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
...and 43 more locations
PK parameters : Maximum Plasma Concentration of IPH4102 alone (All cohorts)
Maximum Plasma Concentration (Cmax) (W1, W5)
Time frame: From the first dose until study completion, an expected average of 2 years
PK parameters :Trough Concentration of IPH4102 alone (All cohorts)
Trough Concentration (Ctrough) every 8 or 12 weeks
Time frame: From the first dose until study completion, an expected average of 2 years
Immunogenicity of IPH4102 alone (All cohorts)
A serum sample will be collected at the specified time points for evaluation of anti-drug antibodies (ADA).
Time frame: From the first dose until study completion, an expected average of 2 years
Duration of Response (DOR)
Time frame: From the first dose until study completion, an expected average of 2 years