Clinical trial • Phase II • Haematology

LACUTAMAB for Peripheral T-cell lymphoma (relapsed/refractory) | PTCL-NOS | PTCL-TFH (including AITL, Follicular T-cell lymphoma) | Anaplastic large cell lymphoma (ALCL) | Adult T-cell leukaemia/lymphoma (ATL) | Hepatosplenic T-cell lymphoma (HSTL) | Enteropathy-associated T-cell lymphoma (EATL) | Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL) | NK/T-cell lymphoma (NKT) | Aggressive NK-cell leukaemia (ANKL)

Phase II trial of LACUTAMAB for Peripheral T-cell lymphoma (relapsed/refractory) | PTCL-NOS | PTCL-TFH (including AITL, Follicular T-cell lymphoma) | Anap…

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Peripheral T-cell lymphoma (relapsed/refractory) | PTCL-NOS | PTCL-TFH (including AITL, Follicular T-cell lymphoma) | Anaplastic large cell lymphoma (ALCL) | Adult T-cell leukaemia/lymphoma (ATL) | Hepatosplenic T-cell lymphoma (HSTL) | Enteropathy-associated T-cell lymphoma (EATL) | Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL) | NK/T-cell lymphoma (NKT) | Aggressive NK-cell leukaemia (ANKL)
Trial Stage
Phase II
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
05-07-2024
First CTIS Authorization Date
09-08-2024

Trial design

Randomised, experimental arm: lacutamab with gemcitabine + oxaliplatin (gemox). control arm: gemcitabine + oxaliplatin (gemox) alone. (doses/schedule not specified in the ctis summary.) Phase II trial in Belgium, Germany, Spain and others.

Randomised
Yes
Comparator
Experimental arm: Lacutamab with Gemcitabine + Oxaliplatin (GemOx). Control arm: Gemcitabine + Oxaliplatin (GemOx) alone. (Doses/schedule not specified in the CTIS summary.)
Biomarker Stratified
True, KIR3DL2 (≥1% tumor cells positivity) required prior to randomization
Target Sample Size
56

Eligibility

Recruits 56 The protocol excludes vulnerable adults unable to provide informed consent: persons deprived of liberty by judicial/administrative decision, persons hospitalized without consent, adults under legal protection, and adults unable to provide informed consent because of intellectual impairment, serious medical condition, abnormal laboratory values or psychiatric illness. Informed consent is required from the participant (signed written screening consent prior to KIR3DL2 screening and signed written study informed consent prior to randomization). No assent procedures for minors are described (participants must be ≥18 years)..

Pregnancy Exclusion
Pregnant or lactating females
Vulnerable Population
The protocol excludes vulnerable adults unable to provide informed consent: persons deprived of liberty by judicial/administrative decision, persons hospitalized without consent, adults under legal protection, and adults unable to provide informed consent because of intellectual impairment, serious medical condition, abnormal laboratory values or psychiatric illness. Informed consent is required from the participant (signed written screening consent prior to KIR3DL2 screening and signed written study informed consent prior to randomization). No assent procedures for minors are described (participants must be ≥18 years).

Inclusion criteria

  • {"criterion_text":"- KIR3DL2-positive with at least 1% of tumor cells positivity, before randomization, based on central evaluation by IHC\n- ECOG performance status 0 to 3 prior to prephase treatment (if applicable), and 0 to 2 prior randomization\n- Minimum life expectancy of 3 months\n- Females of childbearing potential (FCBP) must agree to use highly effective contraceptive method* from C1D1, during the entire study period, during dose interruptions, and for 9 months after the last study treatment\n- FCBP must have a negative serum or urinary pregnancy test within 28 days prior C1D1\n- Male patients and their partner (FCBP) must agree to use two reliable forms of contraception (condom for males and hormonal method for partners) from C1D1, during the entire study period, during dose interruptions, and for 9 months after the last study treatments\n- Patient covered by any social security system (France)\n- Patient who understands and speaks one of the country official languages\n- Patients with histologically documented PTCL: o\tBiopsy-proven treated PTCL defined by the WHO 2016 criteria (the biopsy at relapse is recommended but not mandatory): ▪ PTCL-NOS ▪ PTCL-TFH (AITL, Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype) ▪ ALCL ▪ ATL: acute- or lymphoma-type ▪ HSTL ▪ EATL ▪ MEITL ▪ NKT ▪ ANKL\n- For patients with ALCL: previously treated with brentuximab vedotin\n- Relapsed/refractory PTCL after at least one previous line of systemic based regimen of chemotherapy (no mandatory latency after the previous treatment)\n- With a maximum of 2 prior lines of systemic therapies, including autologous stem cell transplantation (ASCT is authorized in first and second line and is not comptabilized as a unique line, even if associated to a systemic therapy)\n- Bi-dimensionally measurable disease defined by at least one single node or tumor lesion ≥ 1.5 cm assessed by CT scan\n- Signed written screening informed consent prior to KIR3DL2 screening\n- Signed written study informed consent prior to randomization\n- Aged 18 years or more with no upper age limit, at randomization"}

Exclusion criteria

  • {"criterion_text":"- Patients with active COVID-19 infection (last positive PCR < 2 weeks before randomization)\n- Any of the following laboratory abnormalities prior randomization: o\t Absolute neutrophil count (ANC) < 1 G/L, unless neutropenia is related to PTCL o\t Platelet count < 75 G/L, unless thrombopenia is related to PTCL o\t Alkaline Phosphatases > 2.5 x upper limit of normal (ULN) o\t Serum SGOT/AST or SGPT/ALT > 2.5 x ULN o\t Bilirubin > 1.5 x ULN, unless SGOT/AST and SGPT/ALT > 2.5 x ULN or bilirubin elevated due to PTCL or hemolysis o\t Calculated creatinine clearance (MDRD or Cockroft) < 40 mL/min\n- Any significant cardiovascular impairment: New York Heart Association (NYHA) Class III or IV cardiac disease, uncontrolled high blood pressure, unstable angina, myocardial infarction or stroke within the last 6 months from randomization, and cardiac arrhythmia within the last 3 months from randomization\n- Uncontrolled clinically significant intercurrent illness including, but not limited to, diabetes, ongoing active infections. Patients receiving antibiotics for infections that are under control may be included in the study\n- Concurrent malignancy or prior history of malignancies other than lymphoma unless the subject has been free of disease for ≥ 2 years, except early stage cutaneous squamous or basal cell carcinoma, localized prostate cancer, or cervical intraepithelial neoplasia\n- Major surgery within 4 weeks before randomization\n- Pregnant or lactating females\n- Person deprived of his/her liberty by a judicial or administrative decision\n- Person hospitalized without consent\n- Adult person under legal protection\n- Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness\n- Patients taking immunotherapy or chemotherapy, except short-term corticosteroids in monotherapy at a cumulated dose equivalent of prednisone ≤ 1mg/kg/day, during 7 consecutive days, within 3 weeks prior to first administration of study drug (C1D1); or prephase treatment given at investigator’s discretion before randomization and for maximum 3 weeks (glucocorticosteroids, vepeside (VP16), cyclophosphamide, vincristine and prednisone (COP))\n- Extensive radiotherapy (e.g. whole pelvis, half spine) within 3 months before randomization\n- Previous treatment by Gemcitabine or Oxaliplatin\n- Use of any experimental anti-cancer drug therapy within 6 weeks before randomization\n- Contraindication to any drug contained in the study treatment regimen\n- Previous allogenic hematopoietic cell transplantation\n- Positive test results for HIV and HCV (Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation)\n- Known active hepatitis B (positive Ag HBs) (if latent HBV (positive anti-HBc), patients have to be treated with Entecavir (Baraclude ®) and HBV PCR should be performed every month to allow antiviral strategy adapatation)\n- Central nervous system or meningeal involvement by lymphoma"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- modified PFS (mPFS), defined as time from randomization until one of the following events occurs, whichever comes first: a) Disease progression (PD) b) Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT)) c) Relapse after achievement of CR or PR d) Death due to any cause.","definition_or_measurement_approach":"Defined as time from randomization until first occurrence of: (a) disease progression (PD), (b) administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous HCT), (c) relapse after CR or PR, or (d) death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- Response rates according to Lugano classification PET-based","definition_or_measurement_approach":"Response rates assessed per Lugano 2014 criteria (PET-based) (CRR and ORR determined using Lugano 2014 PET criteria)."}
  • {"endpoint_text":"- Response rate assessed by Deauville criteria","definition_or_measurement_approach":"Response assessed using Deauville criteria (PET Deauville scoring)."}
  • {"endpoint_text":"- Duration Of Response (DOR)","definition_or_measurement_approach":"DOR calculated as time from first documented CR or PR per Lugano 2014 criteria (CT/PET-based) until progression, administration of additional unplanned anti-lymphoma treatment (except HCT), relapse after CR/PR, or death."}
  • {"endpoint_text":"- CR rate and ORR according to Lugano 2014 criteria (PET-based)","definition_or_measurement_approach":"Complete response rate (CRR) and overall response rate (ORR) per Lugano 2014 PET-based criteria."}
  • {"endpoint_text":"- subgroup analyses of mPFS, ORR, DOR, OS by PTCL subtype based on previous treatment lines","definition_or_measurement_approach":"Subgroup analyses by PTCL subtype and prior treatment lines for mPFS, ORR, DOR and OS."}
  • {"endpoint_text":"- rate of patients proceeding to allogenic stem cell transplantation","definition_or_measurement_approach":"Proportion of patients who proceed to allogeneic stem cell transplantation during study follow-up."}

Recruitment

Planned Sample Size
56
Recruitment Window Months
72
Consent Approach
Informed consent is required from each participant: a signed written screening informed consent prior to KIR3DL2 screening and a signed written study informed consent prior to randomization. Participants must be adults (≥18 years). Country-specific informed consent documents are provided in available languages (French, German, Dutch, Spanish and English versions of consent/procedure documents are present in the CTIS documents). No assent for minors is described because minors are excluded.

Geography

Total Number Of Sites
65
Total Number Of Participants
56

Belgium

Earliest CTIS Part Ii Submission Date
16-07-2024
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
353
Number Of Sites
11
Number Of Participants
12

Sites

Site Name
CHC MontLegia
Department Name
Hematology
Principal Investigator Name
Renaud ROUFOSSE
Principal Investigator Email
renaud.roufosse@chc.be
Contact Person Name
Renaud ROUFOSSE
Contact Person Email
renaud.roufosse@chc.be
Site Name
Institut Jules Bordet
Department Name
Hematology
Principal Investigator Name
Alice Wolfromm
Principal Investigator Email
alice.wolfromm@hubruxelles.be
Contact Person Name
Alice Wolfromm
Contact Person Email
alice.wolfromm@hubruxelles.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hematology
Principal Investigator Name
Sarah BAILLY
Principal Investigator Email
sarah.bailly@uclouvain.be
Contact Person Name
Sarah BAILLY
Contact Person Email
sarah.bailly@uclouvain.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Hematology
Principal Investigator Name
Marc ANDRE
Principal Investigator Email
cbonnet@uliege.be
Contact Person Name
Marc ANDRE
Contact Person Email
cbonnet@uliege.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Hematology
Principal Investigator Name
Sylvia SNAUWAERT
Principal Investigator Email
sylvia.snauwaert@azsintjan.be
Contact Person Name
Sylvia SNAUWAERT
Contact Person Email
sylvia.snauwaert@azsintjan.be
Site Name
Grand Hopital De Charleroi
Department Name
Hematology
Principal Investigator Name
Delphine PRANGER
Principal Investigator Email
delphine.pranger@ghdc.be
Contact Person Name
Delphine PRANGER
Contact Person Email
delphine.pranger@ghdc.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Hematology
Principal Investigator Name
Claire Maquet
Principal Investigator Email
cmaquet@chuliege.be
Contact Person Name
Claire Maquet
Contact Person Email
cmaquet@chuliege.be
Site Name
Ziekenhuis Aan De Stroom
Department Name
Hematology
Principal Investigator Name
Karolien BEEL
Principal Investigator Email
karolien.beel@zna.be
Contact Person Name
Karolien BEEL
Contact Person Email
karolien.beel@zna.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Hematology
Principal Investigator Name
Matthias Vanderkerken
Principal Investigator Email
matthias.vanderkerken@uza.be
Contact Person Name
Matthias Vanderkerken
Contact Person Email
matthias.vanderkerken@uza.be
Site Name
CHR Verviers
Department Name
Hematology
Principal Investigator Name
Selim SID
Principal Investigator Email
selim.sid@chrverviers.be
Contact Person Name
Selim SID
Contact Person Email
selim.sid@chrverviers.be
Site Name
CHU Helora
Department Name
Hematology
Principal Investigator Name
Marie-Christine NGIRABACU
Principal Investigator Email
mariechristine.ngirabacu@jolimont.be
Contact Person Name
Marie-Christine NGIRABACU

Germany

Earliest CTIS Part Ii Submission Date
16-07-2024
Latest Decision Or Authorization Date
17-07-2025
Processing Time Days
366
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Universitaet Leipzig
Department Name
Hematology
Principal Investigator Name
Marco Herling
Principal Investigator Email
Marco.Herling@medizin.uni-leipzig.de
Contact Person Name
Marco Herling
Site Name
Rotkreuzklinikum Muenchen gGmbH
Department Name
Hematology
Principal Investigator Name
Marcus Hentrich
Principal Investigator Email
marcus.hentrich@swmbrk.de
Contact Person Name
Marcus Hentrich
Contact Person Email
marcus.hentrich@swmbrk.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Hematology
Principal Investigator Name
Barbara Zartner
Principal Investigator Email
Barbara.Zartner@klinik.uni-regensburg.de
Contact Person Name
Barbara Zartner
Site Name
Universitaetsmedizin Goettingen
Department Name
Hematology
Principal Investigator Name
Gerald Wulf
Principal Investigator Email
gerald.wulf@med.uni-goettingen.de
Contact Person Name
Gerald Wulf
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Hematology
Principal Investigator Name
Thomas Weber
Principal Investigator Email
Thomas.weber@uk-halle.de
Contact Person Name
Thomas Weber
Contact Person Email
Thomas.weber@uk-halle.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Hematology
Principal Investigator Name
Björn Chapuy
Principal Investigator Email
bjoern.chapuy@charite.de
Contact Person Name
Björn Chapuy
Contact Person Email
bjoern.chapuy@charite.de

Spain

Earliest CTIS Part Ii Submission Date
16-07-2024
Latest Decision Or Authorization Date
13-10-2025
Processing Time Days
451
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Hospital Clinico Universitario De Valencia
Department Name
Hematology
Principal Investigator Name
Maria José TEROL CASTERA
Principal Investigator Email
Terol_mjo@gva.es
Contact Person Name
Maria José TEROL CASTERA
Contact Person Email
Terol_mjo@gva.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Francesc BOSCH ALBAREDA
Principal Investigator Email
fboschct@vhio.net
Contact Person Name
Francesc BOSCH ALBAREDA
Contact Person Email
fboschct@vhio.net
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Principal Investigator Name
Sonia GONZALEZ DE VILLAMBROSIA
Principal Investigator Email
Sonia.glezdevillambrosi@scsalud.es
Contact Person Name
Sonia GONZALEZ DE VILLAMBROSIA
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Principal Investigator Name
Sergio RAMOS CILLAN
Principal Investigator Email
sergio.ramosc@quironsalud.com
Contact Person Name
Sergio RAMOS CILLAN
Contact Person Email
sergio.ramosc@quironsalud.com

France

Earliest CTIS Part Ii Submission Date
16-07-2024
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
583
Number Of Sites
44
Number Of Participants
20

Sites

Site Name
Institut Bergonie
Department Name
Hematology
Principal Investigator Name
Fontanet BIJOU
Principal Investigator Email
f.bijou@bordeaux.unicancer.fr
Contact Person Name
Fontanet BIJOU
Contact Person Email
f.bijou@bordeaux.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Hematology
Principal Investigator Name
Ludovic FOUILLET
Principal Investigator Email
ludovic.fouillet@icloire.fr
Contact Person Name
Ludovic FOUILLET
Contact Person Email
ludovic.fouillet@icloire.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Hematology
Principal Investigator Name
Gandhi DAMAJ
Principal Investigator Email
damaj-gl@chu-caen.fr
Contact Person Name
Gandhi DAMAJ
Contact Person Email
damaj-gl@chu-caen.fr
Site Name
Assistance Publique Hopitaux De Paris (149 Rue De Sevres)
Department Name
Hematology
Principal Investigator Name
Morgane CHEMINANT
Principal Investigator Email
morgane.cheminant@aphp.fr
Contact Person Name
Morgane CHEMINANT
Contact Person Email
morgane.cheminant@aphp.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Hematology
Principal Investigator Name
Antoine LEVEQUE
Principal Investigator Email
antoine.leveque@ght85.fr
Contact Person Name
Antoine LEVEQUE
Contact Person Email
antoine.leveque@ght85.fr
Site Name
Centre Hospitalier De Perpignan
Department Name
Hematology
Principal Investigator Name
Sara BURCHERI
Principal Investigator Email
sara.burcheri@ch-perpignan.fr
Contact Person Name
Sara BURCHERI
Contact Person Email
sara.burcheri@ch-perpignan.fr
Site Name
Centre Hospitalier Le Mans
Department Name
Hematology
Principal Investigator Name
Kamel LARIBI
Principal Investigator Email
klaribi@ch-lemans.fr
Contact Person Name
Kamel LARIBI
Contact Person Email
klaribi@ch-lemans.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hematology
Principal Investigator Name
Kamal-Krimo BOUABDALLAH
Principal Investigator Email
krimo.bouabdallah@chu-bordeaux.fr
Contact Person Name
Kamal-Krimo BOUABDALLAH
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Hematology
Principal Investigator Name
Sophie BERNARD
Principal Investigator Email
sbernard@ch-cotebasque.fr
Contact Person Name
Sophie BERNARD
Contact Person Email
sbernard@ch-cotebasque.fr
Site Name
Assistance Publique Hopitaux De Paris (1 Avenue Claude Vellefaux)
Department Name
Hematology
Principal Investigator Name
Catherine THIEBLEMONT
Principal Investigator Email
catherine.thieblemont@aphp.fr
Contact Person Name
Catherine THIEBLEMONT
Contact Person Email
catherine.thieblemont@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (184 Rue Du Faubourg Saint Antoine)
Department Name
Hematology
Principal Investigator Name
Laure RICARD
Principal Investigator Email
laure.ricard@aphp.fr
Contact Person Name
Laure RICARD
Contact Person Email
laure.ricard@aphp.fr
Site Name
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name
Hematology
Principal Investigator Name
Mathilde LAMARQUE
Principal Investigator Email
mathilde.lamarque@ghrmsa.fr
Contact Person Name
Mathilde LAMARQUE
Contact Person Email
mathilde.lamarque@ghrmsa.fr
Site Name
Centre Leon Berard
Department Name
Hematology
Principal Investigator Name
Yann GUILLERMIN
Principal Investigator Email
yann.guillermin@lyon.unicancer.fr
Contact Person Name
Yann GUILLERMIN
Site Name
Centre Hospitalier Universitaire De Reims
Department Name
Hematology
Principal Investigator Name
Eric DUROT
Principal Investigator Email
edurot@chu-reims.fr
Contact Person Name
Eric DUROT
Contact Person Email
edurot@chu-reims.fr
Site Name
CHRU De Nancy
Department Name
Hematology
Principal Investigator Name
Moulin Charline
Principal Investigator Email
c.moulin@chru-nancy.fr
Contact Person Name
Moulin Charline
Contact Person Email
c.moulin@chru-nancy.fr
Site Name
Hospices Civils De Lyon
Department Name
Hematology
Principal Investigator Name
Emmanuel BACHY
Principal Investigator Email
emmanuel.bachy@chu-lyon.fr
Contact Person Name
Emmanuel BACHY
Contact Person Email
emmanuel.bachy@chu-lyon.fr
Site Name
Centre Hospitalier D Avignon
Department Name
Hematology
Principal Investigator Name
Borhane SLAMA
Principal Investigator Email
bslama@ch-avignon.fr
Contact Person Name
Borhane SLAMA
Contact Person Email
bslama@ch-avignon.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Hematology
Principal Investigator Name
Agathe WAULTIER-RASCALOU
Principal Investigator Email
agathe.waultier.rascalou@chu-nimes.fr
Contact Person Name
Agathe WAULTIER-RASCALOU
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hematology
Principal Investigator Name
Thomas GASTINNE
Principal Investigator Email
thomas.gastinne@chu-nantes.fr
Contact Person Name
Thomas GASTINNE
Contact Person Email
thomas.gastinne@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hematology
Principal Investigator Name
Stéphanie GUIDEZ
Principal Investigator Email
stephanie.guidez@chu-poitiers.fr
Contact Person Name
Stéphanie GUIDEZ
Site Name
Assistance Publique Hopitaux De Paris (47 Boulevard De L Hopital)
Department Name
Hematology
Principal Investigator Name
Adrien GRENIER
Principal Investigator Email
adrien.grenier@aphp.fr
Contact Person Name
Adrien GRENIER
Contact Person Email
adrien.grenier@aphp.fr
Site Name
L’Hopital Alexandra Lepeve
Department Name
Hematology
Principal Investigator Name
Sarah BARBIEUX
Principal Investigator Email
sarah.barbieux@ch-dunkerque.fr
Contact Person Name
Sarah BARBIEUX
Contact Person Email
sarah.barbieux@ch-dunkerque.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Hematology
Principal Investigator Name
Aline CLAVERT
Principal Investigator Email
aline.clavert@chu-angers.fr
Contact Person Name
Aline CLAVERT
Contact Person Email
aline.clavert@chu-angers.fr
Site Name
Centre Hospitalier Metropole Savoie
Department Name
Hematology
Principal Investigator Name
Arthur DONY
Principal Investigator Email
arthur.dony@ch-metropole-savoie.fr
Contact Person Name
Arthur DONY
Site Name
Centre Hospitalier Bretagne Atlantique
Department Name
Hematology
Principal Investigator Name
Antoine BONNET
Principal Investigator Email
antoine.bonnet@ch-bretagne-atlantique.fr
Contact Person Name
Antoine BONNET
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Hematology
Principal Investigator Name
Steeve CHEVREUX
Principal Investigator Email
steeve.chevreux@chu-dijon.fr
Contact Person Name
Steeve CHEVREUX
Contact Person Email
steeve.chevreux@chu-dijon.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hematology
Principal Investigator Name
Julie ABRAHAM
Principal Investigator Email
julie.abraham@chu-limoges.fr
Contact Person Name
Julie ABRAHAM
Contact Person Email
julie.abraham@chu-limoges.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Hematology
Principal Investigator Name
Pierre MOREL
Principal Investigator Email
morel.pierre@chu-amiens.fr
Contact Person Name
Pierre MOREL
Contact Person Email
morel.pierre@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Hematology
Principal Investigator Name
Sylvain CARRAS
Principal Investigator Email
scarras@chu-grenoble.fr
Contact Person Name
Sylvain CARRAS
Contact Person Email
scarras@chu-grenoble.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hematology
Principal Investigator Name
Luc-Matthieu FORNECKER
Principal Investigator Email
lm.fornecker@icans.eu
Contact Person Name
Luc-Matthieu FORNECKER
Contact Person Email
lm.fornecker@icans.eu
Site Name
Centre Hospitalier De Versailles
Department Name
Hematology
Principal Investigator Name
Hassan FARHAT
Principal Investigator Email
hfarhat@ght78sud.fr
Contact Person Name
Hassan FARHAT
Contact Person Email
hfarhat@ght78sud.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Hematology
Principal Investigator Name
Luc-Matthieu FORNECKER
Principal Investigator Email
luc-matthieu.fornecker@chru-strasbourg.fr
Contact Person Name
Luc-Matthieu FORNECKER
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hematology
Principal Investigator Name
Charles HERBAUX
Principal Investigator Email
c-herbaux@chu-montpellier.fr
Contact Person Name
Charles HERBAUX
Contact Person Email
c-herbaux@chu-montpellier.fr
Site Name
Centre Hospitalier De Perigueux
Department Name
Hematology
Principal Investigator Name
Claire CALMETTES
Principal Investigator Email
claire.calmettes@ch-perigueux.fr
Contact Person Name
Claire CALMETTES
Site Name
Grand Hopital De L Est Francilien
Department Name
Hematology
Principal Investigator Name
Wajed ABARAH
Principal Investigator Email
wabarah@ghef.fr
Contact Person Name
Wajed ABARAH
Contact Person Email
wabarah@ghef.fr
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
Hematology
Principal Investigator Name
Sandy AMORIM
Principal Investigator Email
amorim.sandy@ghicl.net
Contact Person Name
Sandy AMORIM
Contact Person Email
amorim.sandy@ghicl.net
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Hematology
Principal Investigator Name
Olivier TOURNILHAC
Principal Investigator Email
otournilhac@chu-clermontferrand.fr
Contact Person Name
Olivier TOURNILHAC

Sponsor

Primary sponsor

Full Name
LYSARC
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Lacutamab
Active Substance
LACUTAMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
Max daily dose 750 mg; max total dose 21 g
Investigational Product Name
GEMCITABINE
Active Substance
GEMCITABINE
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Maximum Dose
Max daily dose 1000 mg/m2; max total dose 6000 mg/m2
Investigational Product Name
OXALIPLATIN
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Maximum Dose
Max daily dose 100 mg/m2; max total dose 600 mg/m2
Combination Treatment
Yes

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