Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
NCT ID: NCT05429632
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
366 participants
INTERVENTIONAL
2022-06-16
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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3mg mocravimod arm
3 mg of mocravimod orally once per day for 12 months
mocravimod
S1PR modulator
1mg mocravimod arm
1 mg of mocravimod orally once per day for 12 months
mocravimod
S1PR modulator
Placebo arm
placebo orally once per day for 12 months
mocravimod
S1PR modulator
Interventions
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mocravimod
S1PR modulator
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Priothera SAS
INDUSTRY
Responsible Party
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Principal Investigators
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Marcos DeLima, MD
Role: PRINCIPAL_INVESTIGATOR
The Ohio State University Comprehensive Cancer Center
Locations
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University of Alabama Hospital (UAB Hospital)
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, United States
University of California Los Angeles (UCLA) - David Geffen School of Medicine
Los Angeles, California, United States
Emory University - Winship Cancer Institute (WCI)
Atlanta, Georgia, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Ochsner Medical Center (OMC) - New Orleans
New Orleans, Louisiana, United States
University of Maryland Medical Center (UMMC)
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Cancer Institute
Detroit, Michigan, United States
Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)
Grand Rapids, Michigan, United States
University of Rochester Medical Center (URMC)
Rochester, New York, United States
Stony Brook University (SBU) - Cancer Center
Stony Brook, New York, United States
University of Cincinnati Medical Center (University Hospital)
Cincinnati, Ohio, United States
The Ohio State University Comprehensive Cancer Center (OSUCCC)
Cleveland, Ohio, United States
Oregon Health & Science University (OHSU) - Knight Cancer Institute
Portland, Oregon, United States
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Hospital El Cruce - Dr. Nestor Kirchner
Buenos Aires, , Argentina
Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC
Buenos Aires, , Argentina
Sanatorio Allende (SA) - Nueva Cordoba
Córdoba, , Argentina
Hospital Italiano La Plata
La Plata, , Argentina
CEPON - Centro de Pesquisas Oncologicas
Florianópolis, Santa Catarina, Brazil
Hospital Erasto Gaertner
Curicica, , Brazil
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo, , Brazil
Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)
São Paulo, , Brazil
Hospital Israelita Albert Einstein
São Paulo, , Brazil
Unicamp
São Paulo, , Brazil
Hospital Amaral Carvalho
São Paulo, , Brazil
Centre Hospitalier Universitaire (CHU) Angers
Angers, , France
Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez -
Lille, , France
Centre Hospitalier Lyon-Sud
Lyon, , France
CHU de Nantes - Hôtel Dieu
Nantes, , France
Hospital Saint Antoine
Paris, , France
Hôpital Saint Louis
Paris, , France
Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse, , France
Centre de Lutte Contre le Cancer (CLCC) - Institut Gustave-Roussy
Villejuif, , France
Universitätsklinikum Halle
Halle, , Germany
Universitaetsklinikum Jena - Klinik fuer Innere Medizin II
Jena, , Germany
University of Leipzig Medical Center
Leipzig, , Germany
LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen
Munich, , Germany
Rambam Health Care Campus
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, Calabria, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
Alessandria, , Italy
Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno
Ascoli Piceno, , Italy
Azienda Sanitaria Localedella provincia di Brindisi -
Brindisi, , Italy
Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMO
Florence, , Italy
Ospedale Vito Fazzi Lecce
Lecce, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera San Gerardo - Monza
Monza, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Anjo-kosei Hospital
Anjo-shi, Aichi-ken, Japan
Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)
Nagoya, Aichi-ken, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan
Jichi Medical University (JMU) Hospital
Shimotsuke-shi, Tochigi, Japan
Kyushu University Hospital,
Fukuoka, , Japan
Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital
Hiroshima, , Japan
Kobe City Medical Center General Hospital
Kobe, , Japan
Kyoto University Hospital
Kōtoku, , Japan
Ehime Prefectural Centeral Hospital, Ehime
Matsuyama, , Japan
Okayama University Hospital
Okayama, , Japan
Jichi Medical University Saitama Medical Center
Saitama, , Japan
Hokkaido University Hospital
Sapporo, , Japan
Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital
Tokyo, , Japan
Oita University (OU) Hospital
Yufu, , Japan
Sp Zoz Szpital Uniwersytecki W Krakowie
Krakow, Aichi-Ken, Poland
Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) - Slaskie Centrum Hematologii I Transplantacji Szpiku
Katowice, Silesian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk, , Poland
Apteka NSSU
Krakow, , Poland
Centralny Szpital Kliniczny Apteka Szpitalna
Warsaw, , Poland
Institutul Clinic Fundeni
Bucharest, , Romania
Spitalul Clinic Coltea
Bucharest, , Romania
Institutul Regional de Oncologie Iasi, - Haematology Department
Iași, , Romania
Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Barcelona, , Spain
Institut Catala d'Oncologia (ICO)
Barcelona, , Spain
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario de Gran Canaria ""
Las Palmas de Gran Canaria, , Spain
Hospital De La Princesa
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Clinico Universitario - Universidad de Salamanca
Salamanca, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Universitaetsspital Basel
Basel, , Switzerland
Changhua Christian Hospital
Changhua, , Taiwan
National Cheng-Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital (NTUH)
Taipei, , Taiwan
National Taiwan University Cancer Center
Taipei, , Taiwan
Queen Elizabeth Hospital
Birmingham, , United Kingdom
University Hospital of Wales, Cardiff
Cardiff, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
University College Hospital,
London, , United Kingdom
Imperial College, London
London, , United Kingdom
Manchester Royal Infirmary;Manchester University
Manchester, , United Kingdom
Newcastle Upon Tyne Hospitals Norhtern Center for Cancer Care
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Oxford University Hospitals
Oxford, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Marta Pena new PI, MD
Role: backup
Jaime Sanz Caballer, MD
Role: primary
Ko Bor-Sheng, MD
Role: primary
Other Identifiers
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Priothera SAS
Identifier Type: -
Identifier Source: org_study_id
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