Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
- Registration Number
- NCT05429632
- Lead Sponsor
- Priothera SAS
- Brief Summary
This is a multi-center, randomized, double-blinded, placebo controlled trial.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 366
- 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
-
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3mg mocravimod arm mocravimod 3 mg of mocravimod orally once per day for 12 months 1mg mocravimod arm mocravimod 1 mg of mocravimod orally once per day for 12 months Placebo arm mocravimod placebo orally once per day for 12 months
- Primary Outcome Measures
Name Time Method Relapse-free survival (RFS) 12 months To compare the efficacy of mocravimod to that of placebo
- Secondary Outcome Measures
Name Time Method Overall survival (OS) 24 months To compare mocravimod's effect on overall survival (OS) to that of placebo
Trial Locations
- Locations (103)
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
🇧🇷Florianopolis, Santa Catarina, Brazil
Hospital Erasto Gaertner
🇧🇷Curicica, Brazil
Hospital Israelita Albert Einstein
🇧🇷Sao Paulo, Brazil
Unicamp
🇧🇷Sao Paulo, 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 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 HaShomer, Israel
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
🇮🇹Firenze, Italy
Ospedale Vito Fazzi Lecce
🇮🇹Lecce, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
🇮🇹Milano, 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
Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)
🇯🇵Nagoya-shi, Aichi-Ken, Japan
Anjo-kosei Hospital
🇯🇵Anjo-shi, Aichi, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Isikawa, Japan
Institut Catala d'Oncologia (ICO)
🇪🇸Barcelona, Spain
Osaka Metropolitan University Hospital
🇯🇵Osaka-shi, Osaka-Fu, Japan
Jichi Medical University (JMU) Hospital
🇯🇵Shimotsuke-shi, Tochigi-Ken, Japan
Kyushu University Hospital,
🇯🇵Fukuoka-shi, Japan
Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital
🇯🇵Hiroshima-shi, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe-shi, Japan
Kyoto University Hospital
🇯🇵Koto-Ku, Japan
Ehime Prefectural Centeral Hospital, Ehime
🇯🇵Matsuyama-shi, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Jichi Medical University Saitama Medical Center
🇯🇵Saitama, Japan
Hokkaido University Hospital
🇯🇵Sapporo-shi, 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, Silesia, Poland
Uniwersyteckie Centrum Kliniczne (UCK)
🇵🇱Gdansk, Poland
Apteka NSSU
🇵🇱Krakow, Poland
Institutul Clinic Fundeni
🇷🇴Bucharest, Romania
Spitalul Clinic Coltea
🇷🇴Bucharest, Romania
Institutul Regional de Oncologie Iasi, - Haematology Department
🇷🇴Iasi, Romania
Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
🇪🇸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 City, 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