Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

NCT05429632 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: Priothera SAS
• Study Type: interventional
• Target: 366
• Locations: 14 countries
• Sites: 108

Brief Summary

This is a multi-center, randomized, double-blinded, placebo controlled trial.

Conditions

Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival (RFS)

  To compare the efficacy of mocravimod to that of placebo

  12 months

Secondary Outcomes (1)

• Overall survival (OS)

  24 months

Study Arms (3)

3mg mocravimod arm

EXPERIMENTAL

3 mg of mocravimod orally once per day for 12 months

Drug: mocravimod

1mg mocravimod arm

EXPERIMENTAL

1 mg of mocravimod orally once per day for 12 months

Drug: mocravimod

Placebo arm

PLACEBO COMPARATOR

placebo orally once per day for 12 months

Drug: mocravimod

Interventions

mocravimod DRUG

S1PR modulator

1mg mocravimod arm; 3mg mocravimod arm; Placebo arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Priothera SAS: lead

Study Sites (108)

University of Alabama Hospital (UAB Hospital)

Birmingham, Alabama, 35233-1932, United States

RECRUITING

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234-2165, United States

WITHDRAWN

City of Hope Comprehensive Cancer Center - Duarte

Duarte, California, 91010, United States

RECRUITING

University of California Los Angeles (UCLA) - David Geffen School of Medicine

Los Angeles, California, 90095, United States

RECRUITING

UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

WITHDRAWN

Moffitt Cancer Center

Tampa, Florida, 33612, United States

ACTIVE NOT RECRUITING

Emory University - Winship Cancer Institute (WCI)

Atlanta, Georgia, 30322-1013, United States

RECRUITING

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Cancer Center

Westwood, Kansas, 66103, United States

RECRUITING

Ochsner Medical Center (OMC) - New Orleans

New Orleans, Louisiana, 70121, United States

WITHDRAWN

University of Maryland Medical Center (UMMC)

Baltimore, Maryland, 21201-1544, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

WITHDRAWN

Henry Ford Cancer Institute

Detroit, Michigan, 48202-2610, United States

RECRUITING

Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)

Grand Rapids, Michigan, 49503, United States

RECRUITING

University of Rochester Medical Center (URMC)

Rochester, New York, 14642, United States

RECRUITING

Stony Brook University (SBU) - Cancer Center

Stony Brook, New York, 11794-0001, United States

RECRUITING

University of Cincinnati Medical Center (University Hospital)

Cincinnati, Ohio, 45267, United States

RECRUITING

The Ohio State University Comprehensive Cancer Center (OSUCCC)

Cleveland, Ohio, 44106-1716, United States

RECRUITING

Oregon Health & Science University (OHSU) - Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

RECRUITING

University of Pennsylvania - Abramson Cancer Center

Philadelphia, Pennsylvania, 19104-4206, United States

SUSPENDED

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

Hospital El Cruce - Dr. Nestor Kirchner

Buenos Aires, B1884LAD, Argentina

RECRUITING

Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC

Buenos Aires, Argentina

RECRUITING

Sanatorio Allende (SA) - Nueva Cordoba

Córdoba, Argentina

RECRUITING

Hospital Italiano La Plata

La Plata, 1900, Argentina

RECRUITING

CEPON - Centro de Pesquisas Oncologicas

Florianópolis, Santa Catarina, 88034-000, Brazil

RECRUITING

Hospital Erasto Gaertner

Curicica, 81520-060, Brazil

RECRUITING

Hospital Alemao Oswaldo Cruz (HAOC)

São Paulo, 01327-001, Brazil

RECRUITING

Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)

São Paulo, 05403-000, Brazil

RECRUITING

Hospital Israelita Albert Einstein

São Paulo, 05652-900, Brazil

RECRUITING

Unicamp

São Paulo, 13083-878, Brazil

RECRUITING

Hospital Amaral Carvalho

São Paulo, 17210-080, Brazil

RECRUITING

Centre Hospitalier Universitaire (CHU) Angers

Angers, France

RECRUITING

Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez -

Lille, France

RECRUITING

Centre Hospitalier Lyon-Sud

Lyon, 69495, France

RECRUITING

CHU de Nantes - Hôtel Dieu

Nantes, France

RECRUITING

Hospital Saint Antoine

Paris, France

RECRUITING

Hôpital Saint Louis

Paris, France

RECRUITING

Institut Universitaire du Cancer de Toulouse Oncopole

Toulouse, 31059, France

RECRUITING

Centre de Lutte Contre le Cancer (CLCC) - Institut Gustave-Roussy

Villejuif, France

RECRUITING

Universitätsklinikum Halle

Halle, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Jena - Klinik fuer Innere Medizin II

Jena, 07747, Germany

WITHDRAWN

University of Leipzig Medical Center

Leipzig, 04103, Germany

RECRUITING

LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen

Munich, 81377, Germany

ACTIVE NOT RECRUITING

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Hadassah Medical Center

Jerusalem, Israel

RECRUITING

The Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

The Chaim Sheba Medical Center

Tel Litwinsky, Israel

RECRUITING

Grande Ospedale Metropolitano Bianchi Melacrino Morelli

Reggio Calabria, Calabria, 89133, Italy

RECRUITING

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)

San Giovanni Rotondo, Foggia, 71013, Italy

RECRUITING

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria

Alessandria, 15121, Italy

WITHDRAWN

Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno

Ascoli Piceno, 63100, Italy

RECRUITING

Azienda Sanitaria Localedella provincia di Brindisi -

Brindisi, 72100, Italy

WITHDRAWN

Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMO

Florence, Italy

RECRUITING

Ospedale Vito Fazzi Lecce

Lecce, 73100, Italy

RECRUITING

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

Azienda Ospedaliera San Gerardo - Monza

Monza, 20900, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, 61122, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Anjo-kosei Hospital

Anjo-shi, Aichi-ken, 446-8602, Japan

WITHDRAWN

Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)

Nagoya, Aichi-ken, 466-8550, Japan

RECRUITING

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8541, Japan

WITHDRAWN

Osaka Metropolitan University Hospital

Osaka, Osaka, 545-8589, Japan

RECRUITING

Jichi Medical University (JMU) Hospital

Shimotsuke-shi, Tochigi, 329-0498, Japan

WITHDRAWN

Kyushu University Hospital,

Fukuoka, 812-8582, Japan

RECRUITING

Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital

Hiroshima, 730-8619, Japan

RECRUITING

Kobe City Medical Center General Hospital

Kobe, 650-0047, Japan

RECRUITING

Kyoto University Hospital

Kōtoku, 606-8507, Japan

RECRUITING

Ehime Prefectural Centeral Hospital, Ehime

Matsuyama, 790-0024, Japan

WITHDRAWN

Okayama University Hospital

Okayama, 700-8558, Japan

RECRUITING

Jichi Medical University Saitama Medical Center

Saitama, 330-8503, Japan

WITHDRAWN

Hokkaido University Hospital

Sapporo, 060-8648, Japan

RECRUITING

Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital

Tokyo, Japan

RECRUITING

Oita University (OU) Hospital

Yufu, 875593, Japan

WITHDRAWN

Sp Zoz Szpital Uniwersytecki W Krakowie

Krakow, Aichi-Ken, 30-688, Poland

WITHDRAWN

Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) - Slaskie Centrum Hematologii I Transplantacji Szpiku

Katowice, Silesian Voivodeship, Silesia, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne (UCK)

Gdansk, 80-952, Poland

RECRUITING

Apteka NSSU

Krakow, 31-501, Poland

WITHDRAWN

Centralny Szpital Kliniczny Apteka Szpitalna

Warsaw, 02-097, Poland

RECRUITING

Institutul Clinic Fundeni

Bucharest, 022328, Romania

RECRUITING

Spitalul Clinic Coltea

Bucharest, Romania

WITHDRAWN

Institutul Regional de Oncologie Iasi, - Haematology Department

Iași, 700483, Romania

WITHDRAWN

Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

Barcelona, 08035, Spain

RECRUITING

Institut Catala d'Oncologia (ICO)

Barcelona, 8908, Spain

RECRUITING

Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location

Barcelona, 8916, Spain

WITHDRAWN

Hospital Universitario Virgen de las Nieves

Granada, Spain

RECRUITING

Hospital Universitario de Gran Canaria ""

Las Palmas de Gran Canaria, Spain

RECRUITING

Hospital De La Princesa

Madrid, Spain

WITHDRAWN

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, Spain

RECRUITING

Hospital Clinico Universitario - Universidad de Salamanca

Salamanca, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, Spain

RECRUITING

Universitaetsspital Basel

Basel, Switzerland

RECRUITING

Changhua Christian Hospital

Changhua, 500, Taiwan

RECRUITING

National Cheng-Kung University Hospital

Tainan, 70403, Taiwan

WITHDRAWN

National Taiwan University Hospital (NTUH)

Taipei, 10002, Taiwan

RECRUITING

National Taiwan University Cancer Center

Taipei, 106, Taiwan

RECRUITING

Queen Elizabeth Hospital

Birmingham, B152TH, United Kingdom

RECRUITING

University Hospital of Wales, Cardiff

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Queen Elizabeth University Hospital

Glasgow, G514TF, United Kingdom

RECRUITING

University College Hospital,

London, NW1 2BU, United Kingdom

RECRUITING

Imperial College, London

London, United Kingdom

RECRUITING

Manchester Royal Infirmary;Manchester University

Manchester, M139WL, United Kingdom

RECRUITING

Newcastle Upon Tyne Hospitals Norhtern Center for Cancer Care

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

RECRUITING

Oxford University Hospitals

Oxford, United Kingdom

RECRUITING

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Marcos DeLima, MD

  The Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malika Souquieres, MSc

CONTACT

+33 (0) 6 40 91 26 76; malika.souquieres@priothera.com

Jens Hasskarl, MD

CONTACT

+41 79 5432099; jens.hasskarl@priothera.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, multicenter, randomized, double-blind, placebo-controlled, and 3-arm parallel group study

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: June 16, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10); CH (1); GB (10); IT (12); DE (4); FR (8); BR (7); TW (4); JP (15); PL (5); RO (3); AR (4); US (21); IL (4)