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Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
NCT05429632 · Priothera SAS
In plain English
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Official title
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
About this study
The purpose of this study is to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (HCT).
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis
* Diagnosis of macular edema during screening
* Cardiac/pulmonary/hepatic/renal dysfunction
* 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 mg/dL
* Renal dysfunction with estimated creatinine clearance \< 45 mL/min by the Cockcroft-Gault formula
* Diabetes mellitus
* History or presence of uveitis at screening
* History or diagnosis of macular edema
Study design
Enrollment target: 366 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2022-06-16
Estimated completion: 2029-11
Last updated: 2026-04-17
Interventions
Drug: mocravimod
Primary outcomes
- • Relapse-free survival (RFS) (12 months)
Sponsor
Priothera SAS · industry
Contacts & investigators
ContactMalika Souquieres, MSc · contact · malika.souquieres@priothera.com · +33 (0) 6 40 91 26 76
ContactJens Hasskarl, MD · contact · jens.hasskarl@priothera.com · +41 79 5432099
InvestigatorMarcos DeLima, MD · principal_investigator, The Ohio State University Comprehensive Cancer Center
All locations (108)
University of Alabama Hospital (UAB Hospital)Recruiting
Birmingham, Alabama, United States
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
City of Hope Comprehensive Cancer Center - DuarteRecruiting
Duarte, California, United States
University of California Los Angeles (UCLA) - David Geffen School of MedicineRecruiting
Los Angeles, California, United States
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer CenterRecruiting
Aurora, Colorado, United States
Moffitt Cancer CenterActive Not Recruiting
Tampa, Florida, United States
Emory University - Winship Cancer Institute (WCI)Recruiting
Atlanta, Georgia, United States
University of Iowa Hospitals and ClinicsRecruiting
Iowa City, Iowa, United States
University of Kansas Cancer CenterRecruiting
Westwood, Kansas, United States
Ochsner Medical Center (OMC) - New OrleansRecruiting
New Orleans, Louisiana, United States
University of Maryland Medical Center (UMMC)Recruiting
Baltimore, Maryland, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Henry Ford Cancer InstituteRecruiting
Detroit, Michigan, United States
Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)Recruiting
Grand Rapids, Michigan, United States
University of Rochester Medical Center (URMC)Recruiting
Rochester, New York, United States
Stony Brook University (SBU) - Cancer CenterRecruiting
Stony Brook, New York, United States
University of Cincinnati Medical Center (University Hospital)Recruiting
Cincinnati, Ohio, United States
The Ohio State University Comprehensive Cancer Center (OSUCCC)Recruiting
Cleveland, Ohio, United States
Oregon Health & Science University (OHSU) - Knight Cancer InstituteRecruiting
Portland, Oregon, United States
University of Pennsylvania - Abramson Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
Baylor Charles A. Sammons Cancer CenterRecruiting
Dallas, Texas, United States
Hospital El Cruce - Dr. Nestor KirchnerRecruiting
Buenos Aires, Argentina
Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMICRecruiting
Buenos Aires, Argentina
Sanatorio Allende (SA) - Nueva CordobaRecruiting
Córdoba, Argentina
Hospital Italiano La PlataRecruiting
La Plata, Argentina
CEPON - Centro de Pesquisas OncologicasRecruiting
Florianópolis, Santa Catarina, Brazil
Hospital Erasto GaertnerRecruiting
Curicica, Brazil
Hospital Alemao Oswaldo Cruz (HAOC)Recruiting
São Paulo, Brazil
Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)Recruiting
São Paulo, Brazil
Hospital Israelita Albert EinsteinRecruiting
São Paulo, Brazil
UnicampRecruiting
São Paulo, Brazil
Hospital Amaral CarvalhoRecruiting
São Paulo, Brazil
Centre Hospitalier Universitaire (CHU) AngersRecruiting
Angers, France
Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez -Recruiting
Lille, France
Centre Hospitalier Lyon-SudRecruiting
Lyon, France
CHU de Nantes - Hôtel DieuRecruiting
Nantes, France
Hospital Saint AntoineRecruiting
Paris, France
Hôpital Saint LouisRecruiting
Paris, France
Institut Universitaire du Cancer de Toulouse OncopoleRecruiting
Toulouse, France
Centre de Lutte Contre le Cancer (CLCC) - Institut Gustave-RoussyRecruiting
Villejuif, France
Universitätsklinikum HalleActive Not Recruiting
Halle, Germany
Universitaetsklinikum Jena - Klinik fuer Innere Medizin IIRecruiting
Jena, Germany
University of Leipzig Medical CenterRecruiting
Leipzig, Germany
LMU Klinikum Grosshadern Klinikum der Universitaet MuenchenActive Not Recruiting
Munich, Germany
Rambam Health Care CampusRecruiting
Haifa, Israel
Hadassah Medical CenterRecruiting
Jerusalem, Israel
The Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
The Chaim Sheba Medical CenterRecruiting
Tel Litwinsky, Israel
Grande Ospedale Metropolitano Bianchi Melacrino MorelliRecruiting
Reggio Calabria, Calabria, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)Recruiting
San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo AlessandriaRecruiting
Alessandria, Italy
Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli PicenoRecruiting
Ascoli Piceno, Italy
Azienda Sanitaria Localedella provincia di Brindisi -Recruiting
Brindisi, Italy
Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMORecruiting
Florence, Italy
Ospedale Vito Fazzi LecceRecruiting
Lecce, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore PoliclinicoRecruiting
Milan, Italy
Azienda Ospedaliera San Gerardo - MonzaRecruiting
Monza, Italy
Fondazione IRCCS Policlinico San MatteoRecruiting
Pavia, Italy
Azienda Ospedaliera Ospedali Riuniti Marche NordRecruiting
Pesaro, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Roma, Italy
Anjo-kosei HospitalRecruiting
Anjo-shi, Aichi-ken, Japan
Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)Recruiting
Nagoya, Aichi-ken, Japan
Kanazawa University HospitalRecruiting
Kanazawa, Ishikawa-ken, Japan
Osaka Metropolitan University HospitalRecruiting
Osaka, Osaka, Japan
Jichi Medical University (JMU) HospitalRecruiting
Shimotsuke-shi, Tochigi, Japan
Kyushu University Hospital,Recruiting
Fukuoka, Japan
Hiroshima Red Cross Hospital & Atomic-Bomb Survivors HospitalRecruiting
Hiroshima, Japan
Kobe City Medical Center General HospitalRecruiting
Kobe, Japan
Kyoto University HospitalRecruiting
Kōtoku, Japan
Ehime Prefectural Centeral Hospital, EhimeRecruiting
Matsuyama, Japan
Okayama University HospitalRecruiting
Okayama, Japan
Jichi Medical University Saitama Medical CenterRecruiting
Saitama, Japan
Hokkaido University HospitalRecruiting
Sapporo, Japan
Tokyo Metropolitan Cancer and infection Disese Center Komagome HospitalRecruiting
Tokyo, Japan
Oita University (OU) HospitalRecruiting
Yufu, Japan
Sp Zoz Szpital Uniwersytecki W KrakowieRecruiting
Krakow, Aichi-Ken, Poland
Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) - Slaskie Centrum Hematologii I Transplantacji SzpikuRecruiting
Katowice, Silesian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne (UCK)Recruiting
Gdansk, Poland
Apteka NSSURecruiting
Krakow, Poland
Centralny Szpital Kliniczny Apteka SzpitalnaRecruiting
Warsaw, Poland
Institutul Clinic FundeniRecruiting
Bucharest, Romania
Spitalul Clinic ColteaRecruiting
Bucharest, Romania
Institutul Regional de Oncologie Iasi, - Haematology DepartmentRecruiting
Iași, Romania
Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)Recruiting
Barcelona, Spain
Institut Catala d'Oncologia (ICO)Recruiting
Barcelona, Spain
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) LocationRecruiting
Barcelona, Spain
Hospital Universitario Virgen de las NievesRecruiting
Granada, Spain
Hospital Universitario de Gran Canaria ""Recruiting
Las Palmas de Gran Canaria, Spain
Hospital De La PrincesaRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Hospital Clinico Universitario - Universidad de SalamancaRecruiting
Salamanca, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Spain
Universitaetsspital BaselRecruiting
Basel, Switzerland
Changhua Christian HospitalRecruiting
Changhua, Taiwan
National Cheng-Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University Hospital (NTUH)Recruiting
Taipei, Taiwan
National Taiwan University Cancer CenterRecruiting
Taipei, Taiwan
Queen Elizabeth HospitalRecruiting
Birmingham, United Kingdom
University Hospital of Wales, CardiffRecruiting
Cardiff, United Kingdom
Queen Elizabeth University HospitalRecruiting
Glasgow, United Kingdom
University College Hospital,Recruiting
London, United Kingdom
Imperial College, LondonRecruiting
London, United Kingdom
Manchester Royal Infirmary;Manchester UniversityRecruiting
Manchester, United Kingdom
Newcastle Upon Tyne Hospitals Norhtern Center for Cancer CareRecruiting
Newcastle upon Tyne, United Kingdom
Nottingham University Hospitals NHS TrustRecruiting
Nottingham, United Kingdom
Oxford University HospitalsRecruiting
Oxford, United Kingdom
Royal Hallamshire HospitalRecruiting
Sheffield, United Kingdom