Etude : TELLOMAK / IPH4102-201 / Cohorte 1-Relapse/refractory Sezary Syndrome



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : TELLOMAK / IPH4102-201

Nom : Cohorte 1-Relapse/refractory Sezary Syndrome

Traitement :

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 17/10/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : T-cell Lymphoma Anti-KIR3DL2 Therapy. An Open Label, Multicohort, Multi-center Phase II Study Evaluating the Efficacy and Safety of IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T-cell Lymphoma

Spécialité : Peau
Localisation : C44 - Autres tumeurs malignes de la peau
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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, and in patients with peripheral T-cell lymphoma in combination with gemcitabine and oxaliplatin chemotherapy (GEMOX)


Study arms:
- Experimental: Cohort 1: Relapsed/refractory Sezary Syndrome
IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.

Intervention:
- Biological: IPH4102
Patients will receive a flat dose of 750mg
- Drug: Gemcitabine + Oxaliplatin (GEMOX)
Patients will receive a dose ranging from 800-1000 mg/m2 of gemcitabine and 75-100mg/m2 of oxalipatin, according to local practice .


Current primary outcome:
Objective Response Rate (ORR) [ Time Frame: From the first dose until study completion, an expected average of 2 years ]
Using the Olsen (2011, JCO) criteria (Cohorts 1-3), or Lugano Criteria (Cohorts 4-5)

Current secondary outcomes:
- Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) [ Time Frame: From first dose until study completion, an expected average of 2 years ]
patients with treatment-related adverse events as assessed by CTCAE v5.0
- Quality of life (QoL) (Cohorts 1-3) [ Time Frame: Through study completion, an expected average of 2 years ]
Using the Skindex29 questionnaire to assesse the effects of skin disease on quality of life in three domains: Symptoms, Emotions, and Functioning
- pruritus (Cohorts 1-3) [ Time Frame: Through study completion, an expected average of 2 years ]
Using Visual Analog Scale (VAS) for prutitus assessment: From 0 = No pruritus to 10 = Pruritus as bad as it could possibly be
- ORR using central review (Cohort 1) [ Time Frame: From the first dose until study completion, an expected average of 2 years ]
Using the Olsen (2011, JCO) criteria
- ORR lasting at least 4 months (ORR4) (Cohorts 1-3) [ Time Frame: From the first dose until study completion, an expected average of 2 years ]
Using the Olsen (2011, JCO) criteria
- 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 ]
- PK parameters : Maximum Plasma Concentration of IPH4102 alone (Cohorts1-3) or in combination with GEMOX (Cohorts 4 and 5); [ Time Frame: From the first dose until study completion, an expected average of 2 years ]
Maximum Plasma Concentration (Cmax) (W1, W5)
- PK parameters :Trough Concentration of IPH4102 alone (Cohorts1-3) or in combination with GEMOX (Cohorts 4 and 5); [ Time Frame: From the first dose until study completion, an expected average of 2 years ]
Trough Concentration (Ctrough) every 8 or 12 weeks
- Immunogenicity of IPH4102 alone (Cohorts1-3) or in combination with GEMOX (Cohorts 4 and 5); [ Time Frame: From the first dose until study completion, an expected average of 2 years ]
A serum sample will be collected at the specified time points for evaluation of anti-drug antibodies (ADA).
- The impact of treatment on minimal residual disease (MRD) (Cohort 1). [ Time Frame: From the first dose until study completion, an expected average of 2 years ]
A whole blood sample will be collected at the specified time points for evaluation of MRD

Phase : II

Stade : Localement avancé

3, 4, X
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : Cohort 1:
- Patients with relapsed/refractory Sezary Syndrome (SS) who have received at least 2 prior systemic therapies;
- Prior treatment with mogamulizumab;
- Patients should have blood stage B2 at screening based on central evaluation by flow cytometry;
- Feasibility of obtaining at least 1 skin biopsy at screening.

All cohorts:
- Male or Female, at least 18 years of age;
- ECOG performance status ≤2;
- The patient must have a minimum wash-out period of 4 weeks between the last dose of prior systemic therapy (8 weeks for biological agents) and the first dose of IPH4102
- Patients should have recovered from all adverse events related to prior therapy to ≤ grade 1;
- Adequate baseline laboratory data
- Women of childbearing potential (WOCBP) must have a negative serum beta-HCG pregnancy test result within seven days from start of treatment;
- Women of childbearing potential and all men (and their female partners of childbearing potential) who are sexually active must agree to use adequate method of contraception at study entry, during treatment and for at least 9 months (270 days) following the last dose of study drug.

Critères de non-inclusion : Cohorts 1 to 3:
- Patients with evidence of large cell transformation (LCT) based on central histologic evaluation.

All Cohorts:
- Known central nervous system (CNS) lymphoma;
- Prior administration of IPH4102;
- Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents or immunotherapy;
- Autologous stem cell transplantation less than 3 months prior to enrollment;
- Prior allogenic transplantation;
- Concomitant corticosteroid use, systemic or topical. However, stable dosage of topical steroids (maximum strength Class III according to World Health Organization (WHO) Classification of Topical Corticosteroids) and/or systemic steroids (≤10 mg prednisone equivalent/day) are allowed, if patient has been on a stable dose for at least 4 weeks prior to treatment start;
- Patients who have undergone major surgery ≤ 4 weeks prior to study entry;
- Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection;
- Patients who have active Hepatitis B or C virus infection;
- Patients who are known to be HIV-positive;
- Patients with a history of other malignancies during the past 5 years apart from the disease subject of this study. The following are exempt from the five-year limit: non-melanoma skin cancer, lymphomatoid papulosis, resected thyroid cancer, biopsy-proven cervical intraepithelial neoplasia or cervical carcinoma in situ;
- Pregnant or breastfeeding women;
- Patients with congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria;
- Patients with known active autoimmune disease;
- Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol;
- Patients with dementia or altered mental status that would
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03902184
Promoteur :
Innate Pharma
Type de sponsor : Industriel
Innate Pharma
13009 MARSEILLE 09

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Laurent MORTIER

TEC / ARC / IDE :
Benoît MINART
benoit.minart@
chru-lille.fr
03 20 44 64 15

Ouverture de l'essai : OUVERT

MAJ : 17/10/2019