Advanced T-Cell Lymphomas (TCL), i.e. Cutaneous T Cell Lymphomas (CTCL) CTCL subtypes under investigation: relapsed/refractory Sézary Syndrome (SS), stage IB to IV Mycosis Fungoides (MF).
Conditions
Brief summary
Objective response rate (ORR). ORR is defined as the proportion of patients with complete or partial response.
Detailed description
1. Safety Assessment: - AEs, SAEs, change in clinical laboratory evaluations and vital signs., 3. Quality of life: obtained with the patient-reported VAS score for pruritus and QoL questionnaire SkinDex29., 4. Pharmacokinetic (PK) Assessment: Individual IPH4102 serum concentration., 5. Immunogenic potential of IPH4102: Immunogenicity results for each patient., 2.a. Other antitumor activity endpoints: - Duration of response measured from the first documentation of objective response (if subsequently confirmed) to the event of disease progression or death., 2.b. Other antitumor activity endpoints: - Objective response rate (ORR) review of disease response by central review (Cohort 1 only)., 2.c. Other antitumor activity endpoints: - Progression free survival (PFS) from the start of IPH4102 administration to documented progression or death from any cause., 2.d. Other antitumor activity endpoints: - Overall Survival (OS) measured from the start of IPH4102 administration to death from any cause.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR). ORR is defined as the proportion of patients with complete or partial response. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety Assessment: - AEs, SAEs, change in clinical laboratory evaluations and vital signs., 3. Quality of life: obtained with the patient-reported VAS score for pruritus and QoL questionnaire SkinDex29., 4. Pharmacokinetic (PK) Assessment: Individual IPH4102 serum concentration., 5. Immunogenic potential of IPH4102: Immunogenicity results for each patient., 2.a. Other antitumor activity endpoints: - Duration of response measured from the first documentation of objective response (if subsequently confirmed) to the event of disease progression or death., 2.b. Other antitumor activity endpoints: - Objective response rate (ORR) review of disease response by central review (Cohort 1 only)., 2.c. Other antitumor activity endpoints: - Progression free survival (PFS) from the start of IPH4102 administration to documented progression or death from any cause., 2.d. Other antitumor activity endpoints: - Overall Survival (OS) measured from the start of IPH4102 administration to death from any c | — |
Countries
Belgium, France, Germany, Italy, Poland, Spain