RecruitingPhase 3NCT05429632

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

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

Sponsor

Priothera SAS

Enrollment

366 participants

Start Date

Jun 16, 2022

Study Type

INTERVENTIONAL

Conditions

Adult Acute Myeloid Leukemia

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing mocravimod — a drug that helps control where immune cells travel in the body — as an additional treatment alongside a standard stem cell transplant (allogeneic HCT) for patients with acute myeloid leukemia (AML). The goal is to prevent leukemia from coming back while also reducing dangerous immune reactions after transplant. **You may be eligible if:** - You are between 18 and 75 years old - You have AML (not the APL subtype) and are in remission - You are planning a stem cell transplant from a matched donor (related or unrelated, or haploidentical) - Your general health is adequate (ECOG 0–1) - Your organ function (liver, kidney, heart, lungs) is within acceptable limits **You may NOT be eligible if:** - You will be using certain GvHD prevention drugs (cyclosporine, ATG, alemtuzumab, or abatacept) - You have diabetes, a history of macular edema or uveitis (eye conditions) - Your liver or kidney function is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmocravimod

S1PR modulator

Locations(108)

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

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

Aurora, Colorado, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University - Winship Cancer Institute (WCI)

Atlanta, Georgia, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 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

View Full Details on ClinicalTrials.gov

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NCT05429632

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