Etude : TELLOMAK / IPH4102-201 / Cohorte 4 et 5-Relapsed/refractory Peripheral T Cell Lymphoma



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

Nom : Cohorte 4 et 5-Relapsed/refractory Peripheral T Cell Lymphoma

Traitement :

Type d'étude : Hors ciblage moléculaire

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 : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C84 - Lymphomes à cellules T/NK matures

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C86 - Autres types précisés de lymphomes à cellules T/NK
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 4: Peripheral T-cell lymphoma, KIR3DL2 expressing
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.
GEMOX will be administered every 2 weeks for a maximum of 8 cycles

- Experimental: Cohort 5: Peripheral T-cell lymphoma, KIR3DL2 non-expressing
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.
GEMOX will be administered every 2 weeks for a maximum of 8 cycles


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

NA
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 : Cohorts 4 and 5:
- Patients with relapsed/refractory Peripheral T Cell Lymphoma (PTCL) of the following subtypes:
- PTCL-NOS, angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large cell lymphoma (ALCL);
- KIR3DL2 expression (Cohort 4) or non-expression (Cohort 5) by immunohistochemistry performed centrally on at least one involved lymph node;
- Patients should have received at least 1 prior systemic therapy including an anthracycline-based chemotherapy. Patients who are not eligible for treatment with anthracycline based therapy are eligible for inclusion provided that they were treated with at least one prior systemic therapy;
- Presence of at least 1 target lesion on PET/CT scan at screening;
- Feasibility of obtaining 1 lymph node 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 4 and 5:
- Prior administration of gemcitabine and/or oxaliplatin;
- Presence of grade 2 neurotoxicity or higher.

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 Franck MORSCHHAUSER

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Ouverture de l'essai : OUVERT

MAJ : 24/09/2019