Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HCT
Status: Recruiting
Location: See all (108) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Diagnosis of AML (excluding acute promyelocytic leukemia) according to the WHO 2022 classification of AML and related precursor neoplasm, including AML with myelodysplasia-related gene mutations
• European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, \[CRi\] is also allowable
• Planned allogeneic HCT from fully matched related or unrelated donor with no more than 1 antigen mismatch or planned use of haploidentical donor using PBSC graft
• Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5
• Planned use of TAC-based GvHD prophylaxis
• age ≥ 18 years and ≤ 75 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Locations
United States
Alabama
University of Alabama Hospital (UAB Hospital)
ACTIVE_NOT_RECRUITING
Birmingham
Arizona
Banner MD Anderson Cancer Center
WITHDRAWN
Gilbert
California
City of Hope Comprehensive Cancer Center - Duarte
RECRUITING
Duarte
University of California Los Angeles (UCLA) - David Geffen School of Medicine
RECRUITING
Los Angeles
Colorado
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
WITHDRAWN
Aurora
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Georgia
Emory University - Winship Cancer Institute (WCI)
RECRUITING
Atlanta
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Kansas
University of Kansas Cancer Center
RECRUITING
Westwood
Louisiana
Ochsner Medical Center (OMC) - New Orleans
WITHDRAWN
New Orleans
Massachusetts
Massachusetts General Hospital
WITHDRAWN
Boston
Maryland
University of Maryland Medical Center (UMMC)
RECRUITING
Baltimore
Michigan
Henry Ford Cancer Institute
RECRUITING
Detroit
Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)
ACTIVE_NOT_RECRUITING
Grand Rapids
New York
University of Rochester Medical Center (URMC)
RECRUITING
Rochester
Stony Brook University (SBU) - Cancer Center
ACTIVE_NOT_RECRUITING
Stony Brook
Ohio
University of Cincinnati Medical Center (University Hospital)
RECRUITING
Cincinnati
The Ohio State University Comprehensive Cancer Center (OSUCCC)
RECRUITING
Cleveland
Oregon
Oregon Health & Science University (OHSU) - Knight Cancer Institute
RECRUITING
Portland
Pennsylvania
University of Pennsylvania - Abramson Cancer Center
SUSPENDED
Philadelphia
Texas
Baylor Charles A. Sammons Cancer Center
RECRUITING
Dallas
Other Locations
Argentina
Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC
RECRUITING
Buenos Aires
Hospital El Cruce - Dr. Nestor Kirchner
RECRUITING
Buenos Aires
Sanatorio Allende (SA) - Nueva Cordoba
WITHDRAWN
Córdoba
Hospital Italiano La Plata
RECRUITING
La Plata
Brazil
Hospital Erasto Gaertner
RECRUITING
Curicica
CEPON - Centro de Pesquisas Oncologicas
WITHDRAWN
Florianópolis
Hospital Alemao Oswaldo Cruz (HAOC)
RECRUITING
São Paulo
Hospital Amaral Carvalho
RECRUITING
São Paulo
Hospital Israelita Albert Einstein
ACTIVE_NOT_RECRUITING
São Paulo
Unicamp
RECRUITING
São Paulo
Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)
RECRUITING
São Paulo
France
Centre Hospitalier Universitaire (CHU) Angers
RECRUITING
Angers
Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez -
ACTIVE_NOT_RECRUITING
Lille
Centre Hospitalier Lyon-Sud
RECRUITING
Lyon
CHU de Nantes - Hôtel Dieu
ACTIVE_NOT_RECRUITING
Nantes
Hôpital Saint Louis
ACTIVE_NOT_RECRUITING
Paris
Hospital Saint Antoine
RECRUITING
Paris
Institut Universitaire du Cancer de Toulouse Oncopole
ACTIVE_NOT_RECRUITING
Toulouse
Centre de Lutte Contre le Cancer (CLCC) - Institut Gustave-Roussy
RECRUITING
Villejuif
Germany
Universitätsklinikum Halle
RECRUITING
Halle
Universitaetsklinikum Jena - Klinik fuer Innere Medizin II
WITHDRAWN
Jena
University of Leipzig Medical Center
RECRUITING
Leipzig
LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen
ACTIVE_NOT_RECRUITING
Munich
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
The Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
The Chaim Sheba Medical Center
RECRUITING
Tel Litwinsky
Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
WITHDRAWN
Alessandria
Azienda Sanitaria Locale 13 - Ospedale C. e G. Mazzoni- Ascoli Piceno
ACTIVE_NOT_RECRUITING
Ascoli Piceno
Azienda Sanitaria Localedella provincia di Brindisi -
WITHDRAWN
Brindisi
Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMO
RECRUITING
Florence
Ospedale Vito Fazzi Lecce
RECRUITING
Lecce
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Azienda Ospedaliera San Gerardo - Monza
RECRUITING
Monza
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Azienda Ospedaliera Ospedali Riuniti Marche Nord
RECRUITING
Pesaro
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
RECRUITING
Reggio Calabria
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
ACTIVE_NOT_RECRUITING
San Giovanni Rotondo
Japan
Anjo-kosei Hospital
WITHDRAWN
Anjo-shi
Kyushu University Hospital,
RECRUITING
Fukuoka
Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital
ACTIVE_NOT_RECRUITING
Hiroshima
Kanazawa University Hospital
WITHDRAWN
Kanazawa
Kobe City Medical Center General Hospital
ACTIVE_NOT_RECRUITING
Kobe
Kyoto University Hospital
ACTIVE_NOT_RECRUITING
Kōtoku
Ehime Prefectural Centeral Hospital, Ehime
WITHDRAWN
Matsuyama
Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)
RECRUITING
Nagoya
Okayama University Hospital
ACTIVE_NOT_RECRUITING
Okayama
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Jichi Medical University Saitama Medical Center
WITHDRAWN
Saitama
Hokkaido University Hospital
RECRUITING
Sapporo
Jichi Medical University (JMU) Hospital
WITHDRAWN
Shimotsuke-shi
Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital
ACTIVE_NOT_RECRUITING
Tokyo
Oita University (OU) Hospital
WITHDRAWN
Yufu
Poland
Uniwersyteckie Centrum Kliniczne (UCK)
RECRUITING
Gdansk
Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) - Slaskie Centrum Hematologii I Transplantacji Szpiku
ACTIVE_NOT_RECRUITING
Katowice
Apteka NSSU
WITHDRAWN
Krakow
Sp Zoz Szpital Uniwersytecki W Krakowie
WITHDRAWN
Krakow
Centralny Szpital Kliniczny Apteka Szpitalna
RECRUITING
Warsaw
Romania
Institutul Clinic Fundeni
RECRUITING
Bucharest
Spitalul Clinic Coltea
WITHDRAWN
Bucharest
Institutul Regional de Oncologie Iasi, - Haematology Department
WITHDRAWN
Iași
Spain
Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
RECRUITING
Barcelona
Institut Catala d'Oncologia (ICO)
RECRUITING
Barcelona
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location
WITHDRAWN
Barcelona
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Hospital Universitario de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
Hospital De La Princesa
WITHDRAWN
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Clinico Universitario - Universidad de Salamanca
RECRUITING
Salamanca
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Switzerland
Universitaetsspital Basel
RECRUITING
Basel
Taiwan
Changhua Christian Hospital
WITHDRAWN
Changhua
National Cheng-Kung University Hospital
WITHDRAWN
Tainan
National Taiwan University Cancer Center
RECRUITING
Taipei
National Taiwan University Hospital (NTUH)
RECRUITING
Taipei
United Kingdom
Queen Elizabeth Hospital
RECRUITING
Birmingham
University Hospital of Wales, Cardiff
RECRUITING
Cardiff
Queen Elizabeth University Hospital
RECRUITING
Glasgow
Imperial College, London
ACTIVE_NOT_RECRUITING
London
University College Hospital,
RECRUITING
London
Manchester Royal Infirmary;Manchester University
RECRUITING
Manchester
Newcastle Upon Tyne Hospitals Norhtern Center for Cancer Care
RECRUITING
Newcastle Upon Tyne
Nottingham University Hospitals NHS Trust
ACTIVE_NOT_RECRUITING
Nottingham
Oxford University Hospitals
RECRUITING
Oxford
Royal Hallamshire Hospital
RECRUITING
Sheffield
Contact Information
Primary
Malika Souquieres, MSc
malika.souquieres@priothera.com
+33 (0) 6 40 91 26 76
Backup
Jens Hasskarl, MD
jens.hasskarl@priothera.com
+41 79 5432099
Time Frame
Start Date: 2022-06-16
Estimated Completion Date: 2029-11
Participants
Target number of participants: 366
Treatments
Experimental: 3mg mocravimod arm
3 mg of mocravimod orally once per day for 12 months
Experimental: 1mg mocravimod arm
1 mg of mocravimod orally once per day for 12 months
Placebo_comparator: Placebo arm
placebo orally once per day for 12 months
Related Therapeutic Areas
Sponsors
Leads: Priothera SAS