Clinical trial • Phase III • Oncology|Haematology

MOCRAVIMOD for Acute myeloid leukemia

Phase III trial of MOCRAVIMOD for Acute myeloid leukemia.

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Acute myeloid leukemia
Trial Stage
Phase III
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
17-07-2024
First CTIS Authorization Date
08-08-2024

Trial design

Randomised, placebo — hard capsules containing maize starch, microcrystalline cellulose, magnesium stearate (oral capsules). active comparator arms: mocravimod (krp203) doses 1 mg and 3 mg (oral).-controlled Phase III trial in France, Germany, Italy and others.

Randomised
Yes
Comparator
Placebo — Hard capsules containing maize starch, microcrystalline cellulose, magnesium stearate (oral capsules). Active comparator arms: Mocravimod (KRP203) doses 1 mg and 3 mg (oral).
Target Sample Size
229
Trial Duration For Participant
365

Eligibility

Recruits 229 adults.

Inclusion criteria

  • {"criterion_text":"- Subjects with a diagnosis of AML (excluding acute promyelocytic leukemia) according to the World Health Organization (WHO) 2022 classification of AML and related precursor neoplasms, including therapy AML with myelodysplasia related gene mutations."}
  • {"criterion_text":"- Subjects with European LeukemiaNet (ELN) high risk or intermediate risk or AML in CR1, or AML of any risk in CR2. (Complete remission with incomplete count recovery [CRi] is also allowable). - Complete remission is defined as: < 5% marrow blasts by morphologic examination and no circulating peripheral blasts; absence of extramedullary disease; absolute neutrophil count ≥ 1.0x109/L (1000/μL); platelet count ≥ 100x109/L (100 000/μL) - CRi is defined as meeting all complete remission criteria except for residual absolute neutropenia < 1000/μL and/or thrombocytopenia <100 000/μL"}
  • {"criterion_text":"- Planned use of a related or unrelated donor or with no more than 1 antigen mismatch or planned use of a haploidentical donor"}
  • {"criterion_text":"- Life expectancy ≥ 6 months at screening."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"}
  • {"criterion_text":"- Male or female, age ≥ 18 years and ≤ 75 years."}

Exclusion criteria

  • {"criterion_text":"- Planned use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis."}
  • {"criterion_text":"- Subjects having received prior allogeneic HCT or recipients of a solid organ transplant."}
  • {"criterion_text":"- Immunosuppressive drugs for concomitant disease. Subjects must be able to be off prednisone (> 10 mg/day) or other immunosuppressive medications for at least 3 days prior to the start of treatment of the study. Physiologic replacement dosing of hydrocortisone is permissible."}
  • {"criterion_text":"- Require treatments for cardiac dysfunction"}
  • {"criterion_text":"- Subjects with acute promyelocytic leukemia."}
  • {"criterion_text":"- Blast crisis of chronic myeloid leukemia"}
  • {"criterion_text":"- Cardiac dysfunction"}
  • {"criterion_text":"- Pulmonary dysfunction."}
  • {"criterion_text":"- Significant liver disease or liver injury or known history of alcohol abuse, chronic liver or biliary disease. Hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN); or total bilirubin > 1.5 x ULN"}
  • {"criterion_text":"- Renal dysfunction with creatinine clearance < 45 mL/min by the Cockcroft-Gault formula."}
  • {"criterion_text":"- History of stroke or intracranial hemorrhage within 1 year prior to screening."}
  • {"criterion_text":"- Active clinically significant infection (viral, bacterial, or fungal) that requires ongoing antimicrobial therapy and in the judgment of the investigator represents a risk to proceeding with HCT."}
  • {"criterion_text":"- Planned use of serotherapy during conditioning, including ATG and alemtuzumab."}
  • {"criterion_text":"- Planned ex vivo major graft manipulation, including T-cell depletion or CD34+ selection."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Relapse-free survival (RFS)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival (OS) - mocravimod's effect on OS to that to placebo","definition_or_measurement_approach":""}
  • {"endpoint_text":"- RFS at EOS (End-of-study) - to assess the sustained efficacy of moc in comparison to placebo","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Survival free from Grade III/IV aGvHD at 12 mo & time to acute GvHD","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Survival free from moderate /severe cGvHD at EOS & time to cGvHD","definition_or_measurement_approach":""}
  • {"endpoint_text":"- GRFS (GvHD-free, Relapse-free survival at 12 mo and at EOS)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
229
Recruitment Window Months
71
Consent Approach
Adult participants (age ≥18 years) provide written informed consent. Country-specific subject information and informed consent forms are available (documented versions in Romanian, Spanish, Polish, Italian, German and French). No participant assent process for minors is indicated (trial population restricted to adults).

Geography

Total Number Of Sites
49
Total Number Of Participants
188

France

Earliest CTIS Part Ii Submission Date
09-07-2024
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
640
Number Of Sites
10
Number Of Participants
40

Sites

Site Name
CHRU De Nancy
Department Name
Service d’Hematologie Clinique
Principal Investigator Name
Simona Pagliuca
Principal Investigator Email
S.PAGLIUCA@chru-nancy.fr
Contact Person Name
Simona Pagliuca
Contact Person Email
S.PAGLIUCA@chru-nancy.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'Hematologie Seniors
Principal Investigator Name
Marie Robin
Principal Investigator Email
marie.robin@aphp.fr
Contact Person Name
Marie Robin
Contact Person Email
marie.robin@aphp.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Service des Maladies du Sang
Principal Investigator Name
Sylvain Thepot
Principal Investigator Email
sylvain.thepot@chu-angers.fr
Contact Person Name
Sylvain Thepot
Contact Person Email
sylvain.thepot@chu-angers.fr
Site Name
Hospital Hotel Dieu
Department Name
Centre d'Investigation Clinique Hématologie
Principal Investigator Name
Patrice Chevallier
Principal Investigator Email
patrice.chevallier@chu-nantes.fr
Contact Person Name
Patrice Chevallier
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Département d'hématologie et de thérapie Cellulaire
Principal Investigator Name
Florent Malard
Principal Investigator Email
florent.malard@inserm.fr
Contact Person Name
Florent Malard
Contact Person Email
florent.malard@inserm.fr
Site Name
Hospices Civils De Lyon
Department Name
Hematology Department
Principal Investigator Name
Mael Heiblig
Principal Investigator Email
mael.heiblig@chu-lyon.fr
Contact Person Name
Mael Heiblig
Contact Person Email
mael.heiblig@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hematology Department
Principal Investigator Name
Anne Huynh
Principal Investigator Email
huynh.anne@iuct-oncopole.fr
Contact Person Name
Anne Huynh
Contact Person Email
huynh.anne@iuct-oncopole.fr
Site Name
Hopital Huriez
Department Name
Service des maladies du sang
Principal Investigator Name
Valérie Coiteux
Principal Investigator Email
valerie.coiteux@chu-lille.fr
Contact Person Name
Valérie Coiteux
Contact Person Email
valerie.coiteux@chu-lille.fr
Site Name
Institut Gustave Roussy
Department Name
Service cancer hematologique
Principal Investigator Name
Cristina Castilla-LLorente
Contact Person Name
Cristina Castilla-LLorente
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hematology
Principal Investigator Name
Ambroise Marçais
Principal Investigator Email
ambroise.marcais@chru-strasbourg.fr
Contact Person Name
Ambroise Marçais

Germany

Earliest CTIS Part Ii Submission Date
09-07-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
581
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Internal Medicine IV (Hematology and Oncology)
Principal Investigator Name
Lutz P. Müller
Principal Investigator Email
lutz.mueller@uk-halle.de
Contact Person Name
Lutz P. Müller
Contact Person Email
lutz.mueller@uk-halle.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik II
Principal Investigator Name
Jochen Frietsch
Principal Investigator Email
Frietsch-j@ukw.de
Contact Person Name
Jochen Frietsch
Contact Person Email
Frietsch-j@ukw.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medical Clinic and Policlinic III – Oncology and Hematology
Principal Investigator Name
Michael von Bergwelt
Principal Investigator Email
michael.bergwelt@med.uni-muenchen.de
Contact Person Name
Michael von Bergwelt
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Innere Medizin I
Principal Investigator Name
Robert Zeiser
Principal Investigator Email
robert.zeiser@uniklinik-freiburg.de
Contact Person Name
Robert Zeiser
Site Name
Universitaetsklinikum Jena KöR
Department Name
Department of Hematology and Internal Oncology
Principal Investigator Name
Inken Hilgendorf
Principal Investigator Email
inken.hilgendorf@med.uni-jena.de
Contact Person Name
Inken Hilgendorf
Site Name
Universitaet Leipzig
Department Name
Medical Department for Hematology, Cell Therapy and Hemostaseolo gy; Division Hematology and Cell Th
Principal Investigator Name
Georg-Nikolaus Franke
Contact Person Name
Georg-Nikolaus Franke
Site Name
University Hospital Cologne AöR
Department Name
Internal Medicine I
Principal Investigator Name
Udo Holtick
Principal Investigator Email
udo.holtick@uk-koeln.de
Contact Person Name
Udo Holtick
Contact Person Email
udo.holtick@uk-koeln.de

Italy

Earliest CTIS Part Ii Submission Date
09-07-2024
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
519
Number Of Sites
12
Number Of Participants
20

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Department of Hematology — Bone Marrow Transplantation Center
Principal Investigator Name
Giorgia Saporiti
Principal Investigator Email
giorgia.saporiti@policlinico.mi.it
Contact Person Name
Giorgia Saporiti
Site Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Department Name
CTMO
Principal Investigator Name
Maria Caterina Micò
Principal Investigator Email
mariacaterina.mico@ospedalerc.it
Contact Person Name
Maria Caterina Micò
Site Name
Casa Sollievo Della Sofferenza
Department Name
Hematology Department
Principal Investigator Name
Angelo Michele Carella
Principal Investigator Email
am.carella@operapadrepio.it
Contact Person Name
Angelo Michele Carella
Contact Person Email
am.carella@operapadrepio.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Hematology Division and Bone Marrow Transplant Unit
Principal Investigator Name
Elisabetta Terruzzi
Principal Investigator Email
e.terruzzi@hsgerardo.org
Contact Person Name
Elisabetta Terruzzi
Contact Person Email
e.terruzzi@hsgerardo.org
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Unit of Bone Marrow Transplantation Division of Hematology
Principal Investigator Name
Nicola Polverelli
Principal Investigator Email
n.polverelli@smatteo.pv.it
Contact Person Name
Nicola Polverelli
Contact Person Email
n.polverelli@smatteo.pv.it
Site Name
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Department Name
Hematology and Stem Cell Transplant Center
Principal Investigator Name
Barbara Guiducci
Principal Investigator Email
barbara.guiducci@sanita.marche.it
Contact Person Name
Barbara Guiducci
Site Name
Ospedale Vito Fazzi Lecce
Department Name
Oncology
Principal Investigator Name
Nicola Di Renzo
Principal Investigator Email
direnzo.ematolecce@gmail.com
Contact Person Name
Nicola Di Renzo
Contact Person Email
direnzo.ematolecce@gmail.com
Site Name
Careggi University Hospital
Department Name
Cellular therapy and transfusion Medicine unit
Principal Investigator Name
Antonella Gozzini
Principal Investigator Email
gozzinia@aou-careggi.toscana.it
Contact Person Name
Antonella Gozzini
Site Name
Azienda Sanitaria Locale Br
Department Name
Complex Operating Unit of Hematology and Transplantation
Principal Investigator Name
Alessandro Spina
Principal Investigator Email
al.spina5651@gmail.com
Contact Person Name
Alessandro Spina
Contact Person Email
al.spina5651@gmail.com
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Imaging Diagnostics, Oncological Radiotherapy and Haematology
Principal Investigator Name
Simona Sica
Principal Investigator Email
simona.sica@unicatt.it
Contact Person Name
Simona Sica
Contact Person Email
simona.sica@unicatt.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
SC of Hematology
Principal Investigator Name
Lucia Brunello
Principal Investigator Email
lucia.brunello@ospedale.al.it
Contact Person Name
Lucia Brunello
Contact Person Email
lucia.brunello@ospedale.al.it
Site Name
Azienda Sanitaria Territoriale Di Ascoli Piceno
Department Name
U.O. Hematology
Principal Investigator Name
Piero Galieni
Principal Investigator Email
piero.galieni@sanita.marche.it
Contact Person Name
Piero Galieni
Contact Person Email
piero.galieni@sanita.marche.it

Romania

Earliest CTIS Part Ii Submission Date
09-07-2024
Latest Decision Or Authorization Date
08-09-2025
Processing Time Days
426
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Spitalul Clinic Coltea
Department Name
Hematology
Principal Investigator Name
Gabriela Borsaru
Principal Investigator Email
gabriex2001@yahoo.it
Contact Person Name
Gabriela Borsaru
Contact Person Email
gabriex2001@yahoo.it
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Hematology
Principal Investigator Name
Angela Smaranda Dascalescu
Principal Investigator Email
angdascalescu@yahoo.com
Contact Person Name
Angela Smaranda Dascalescu
Contact Person Email
angdascalescu@yahoo.com
Site Name
Institutul Clinic Fundeni
Department Name
Hematology
Principal Investigator Name
Alina Daniela Tanase
Principal Investigator Email
alinadanielatanase@yahoo.com
Contact Person Name
Alina Daniela Tanase
Contact Person Email
alinadanielatanase@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
09-07-2024
Latest Decision Or Authorization Date
08-08-2025
Processing Time Days
395
Number Of Sites
10
Number Of Participants
80

Sites

Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Hematology Department
Principal Investigator Name
Pedro Antonio González Sierra
Principal Investigator Email
pedroa.gonzalez.sspa@juntadeandalucia.es
Contact Person Name
Pedro Antonio González Sierra
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Hematology Department
Principal Investigator Name
Melissa Karina Torres Ochando
Principal Investigator Email
m.torresochando@gmail.com
Contact Person Name
Melissa Karina Torres Ochando
Contact Person Email
m.torresochando@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Hematology Department
Principal Investigator Name
Marta Peña Domingo
Principal Investigator Email
mpena@iconcologia.net
Contact Person Name
Marta Peña Domingo
Contact Person Email
mpena@iconcologia.net
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology Department
Principal Investigator Name
Juan Montoro Gómez
Principal Investigator Email
montoro_jua@gva.es
Contact Person Name
Juan Montoro Gómez
Contact Person Email
montoro_jua@gva.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology Department
Principal Investigator Name
David Valcárcel Ferreiras
Principal Investigator Email
dvalcarcel@vhio.net
Contact Person Name
David Valcárcel Ferreiras
Contact Person Email
dvalcarcel@vhio.net
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology Department
Principal Investigator Name
Estefanía Pérez López
Principal Investigator Email
eperezl@saludcastillayleon.es
Contact Person Name
Estefanía Pérez López
Contact Person Email
eperezl@saludcastillayleon.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology Department
Principal Investigator Name
Maria Calbacho Robles
Principal Investigator Email
maria.calbacho@salud.madrid.org
Contact Person Name
Maria Calbacho Robles
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology Department
Principal Investigator Name
Anabelle Chinea Rodríguez
Principal Investigator Email
anabelle.chinea@salud.madrid.org
Contact Person Name
Anabelle Chinea Rodríguez
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Hematology Department
Principal Investigator Name
María Huguet Mas
Principal Investigator Email
uicico_badalona@iconcologia.net
Contact Person Name
María Huguet Mas
Site Name
Hospital Universitario De La Princesa
Department Name
Hematology Department
Principal Investigator Name
María Del Valle Gómez García de Soria
Principal Investigator Email
vallegomez@yahoo.com
Contact Person Name
María Del Valle Gómez García de Soria
Contact Person Email
vallegomez@yahoo.com

Poland

Earliest CTIS Part Ii Submission Date
09-07-2024
Latest Decision Or Authorization Date
23-10-2025
Processing Time Days
471
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Odział Hematologii I Transplantacji Szpiku
Principal Investigator Name
Agata Wieczorkiewicz-Kabut
Principal Investigator Email
wieczorkiewicza@tlen.pl
Contact Person Name
Agata Wieczorkiewicz-Kabut
Contact Person Email
wieczorkiewicza@tlen.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Hematologii
Principal Investigator Name
Patrycja Mensah-Glanowska
Principal Investigator Email
patrycja.mensah-glanowska@uj.edu.pl
Contact Person Name
Patrycja Mensah-Glanowska
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oddział Hematologiczny
Principal Investigator Name
Jarosław Dybko
Principal Investigator Email
jdybko@dctk.wroc.pl
Contact Person Name
Jarosław Dybko
Contact Person Email
jdybko@dctk.wroc.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
-
Principal Investigator Name
Agnieszka Piekarska
Principal Investigator Email
agnieszka.piekarska@gumed.edu.pl
Contact Person Name
Agnieszka Piekarska
Site Name
Instytut Hematologii I Transfuzjologii
Department Name
Klinika Transplantacji Komórek IHiT
Principal Investigator Name
Kazimierz Hałaburda
Principal Investigator Email
onkocwbk@ihit.waw.pl
Contact Person Name
Kazimierz Hałaburda
Contact Person Email
onkocwbk@ihit.waw.pl
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Klinika Transplantacji Komórek Krwiotwórczych
Principal Investigator Name
Grzegorz Basak
Principal Investigator Email
Grzegorz.basak@wum.edu.pl
Contact Person Name
Grzegorz Basak
Contact Person Email
Grzegorz.basak@wum.edu.pl
Site Name
Samodzielny Publiczny Szpital Kliniczny ... Katowice (duplicate listing)
Department Name
Odział Hematologii I Transplantacji Szpiku

Sponsor

Primary sponsor

Full Name
Priothera S.A.S.
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Multiple sponsor responsibilities (codes: 1,11,12,2,3,6,7,8)

Third parties

  • {"country":"France","full_name":"Marken","duties_or_roles":"Kit building and sample shipment","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"SGS France","duties_or_roles":"Bioanalysis (PK)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Precision for Medicine GmbH","duties_or_roles":"Immunophenotyping","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"EDC/RTSM","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"eDiary, patient questionnaire development","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Insel Gruppe AG","duties_or_roles":"Kit building and sample shipment","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"IP labelling and distribution","organisation_type":"Pharmaceutical company"}
  • {"country":"Cyprus","full_name":"Clinbay Limited","duties_or_roles":"Unspecified (code 10)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Multiple sponsor responsibilities (codes: 1,11,12,2,3,6,7,8)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"patient reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"MRD testing","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Mocravimod (KRP203)
Active Substance
MOCRAVIMOD
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Orphan Designation
Yes
Starting Dose
1 mg
Dose Levels
1 mg|3 mg
Maximum Dose
3 mg daily
Investigational Product Name
Hard capsules containing maize starch, microcrystalline cellulose, magnesium stearate (Placebo)
Modality
Other
Combination Treatment
Yes

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