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NCT05429632PHASE3Recruiting

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

Priothera SAS

Start Date

6/16/2022

Completion Date

11/1/2029

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).

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

mocravimod

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Conditions

Adult Acute Myeloid Leukemia

Locations

University of Alabama Hospital (UAB Hospital)

Birmingham, Alabama 35233-1932

United States

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234-2165

United States

City of Hope Comprehensive Cancer Center - Duarte

Duarte, California 91010

United States

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

Los Angeles, California 90095

United States

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

Aurora, Colorado 80045

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Emory University - Winship Cancer Institute (WCI)

Atlanta, Georgia 30322-1013

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242

United States

University of Kansas Cancer Center

Westwood, Kansas 66103

United States

Ochsner Medical Center (OMC) - New Orleans

New Orleans, Louisiana 70121

United States

University of Maryland Medical Center (UMMC)

Baltimore, Maryland 21201-1544

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Henry Ford Cancer Institute

Detroit, Michigan 48202-2610

United States

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

Grand Rapids, Michigan 49503

United States

University of Rochester Medical Center (URMC)

Rochester, New York 14642

United States

Stony Brook University (SBU) - Cancer Center

Stony Brook, New York 11794-0001

United States

University of Cincinnati Medical Center (University Hospital)

Cincinnati, Ohio 45267

United States

The Ohio State University Comprehensive Cancer Center (OSUCCC)

Cleveland, Ohio 44106-1716

United States

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

Portland, Oregon 97239-3098

United States

University of Pennsylvania - Abramson Cancer Center

Philadelphia, Pennsylvania 19104-4206

United States

Baylor Charles A. Sammons Cancer Center

Dallas, Texas 75246

United States

Hospital El Cruce - Dr. Nestor Kirchner

Buenos Aires, B1884LAD

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, 1900

Argentina

CEPON - Centro de Pesquisas Oncologicas

Florianópolis, Santa Catarina 88034-000

Brazil

Hospital Erasto Gaertner

Curicica, 81520-060

Brazil

Hospital Alemao Oswaldo Cruz (HAOC)

São Paulo, 01327-001

Brazil

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

São Paulo, 05403-000

Brazil

Hospital Israelita Albert Einstein

São Paulo, 05652-900

Brazil

Unicamp

São Paulo, 13083-878

Brazil

Hospital Amaral Carvalho

São Paulo, 17210-080

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, 69495

France

CHRU Nancy Hopitaux de Brabois

Nancy,

France

CHU de Nantes - Hôtel Dieu

Nantes,

France

Hospital Saint Antoine

Paris,

France

Hôpital Saint Louis

Paris,

France

Strasbourg (UIC d'onco-hématologie - Hôpital de Hautepierre)

Strasbourg,

France

Institut Universitaire du Cancer de Toulouse Oncopole

Toulouse, 31059

France

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

Villejuif,

France

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg 79106

Germany

Universitätsklinikum Halle

Halle,

Germany

Universitaetsklinikum Jena - Klinik fuer Innere Medizin II

Jena, 07747

Germany

University of Leipzig Medical Center

Leipzig, 04103

Germany

LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen

Munich, 81377

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

Azienda Sanitaria Localedella provincia di Brindisi -

Brindisi, Brindisi 72100

Italy

Grande Ospedale Metropolitano Bianchi Melacrino Morelli

Reggio Calabria, Calabria 89133

Italy

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

San Giovanni Rotondo, Foggia 71013

Italy

Ospedale Vito Fazzi Lecce

Lecce, Lecce 73100

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Roma 00168

Italy

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

Alessandria, 15121

Italy

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

Ascoli Piceno, 63100

Italy

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

Florence,

Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan,

Italy

Azienda Ospedaliera San Gerardo - Monza

Monza, 20900

Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100

Italy

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, 61122

Italy

Anjo-kosei Hospital

Anjo-shi, Aichi-ken 446-8602

Japan

Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)

Nagoya, Aichi-ken 466-8550

Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken 920-8541

Japan

Osaka Metropolitan University Hospital

Osaka, Osaka 545-8589

Japan

Jichi Medical University Saitama Medical Center

Saitama, Saitama 330-8503

Japan

Jichi Medical University (JMU) Hospital

Shimotsuke-shi, Tochigi 329-0498

Japan

Kyushu University Hospital,

Fukuoka, 812-8582

Japan

Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital

Hiroshima, 730-8619

Japan

Kobe City Medical Center General Hospital

Kobe, 650-0047

Japan

Kyoto University Hospital

Kōtoku, 606-8507

Japan

Ehime Prefectural Centeral Hospital, Ehime

Matsuyama, 790-0024

Japan

Okayama University Hospital

Okayama, 700-8558

Japan

Hokkaido University Hospital

Sapporo, 060-8648

Japan

Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital

Tokyo,

Japan

Oita University (OU) Hospital

Yufu, 875593

Japan

Sp Zoz Szpital Uniwersytecki W Krakowie

Krakow, Aichi-Ken 30-688

Poland

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

Uniwersyteckie Centrum Kliniczne (UCK)

Gdansk, 80-952

Poland

Apteka NSSU

Krakow, 31-501

Poland

Centralny Szpital Kliniczny Apteka Szpitalna

Warsaw, 02-097

Poland

Institutul Clinic Fundeni

Bucharest, 022328

Romania

Spitalul Clinic Coltea

Bucharest,

Romania

Institutul Regional de Oncologie Iasi, - Haematology Department

Iași, 700483

Romania

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

Barcelona, 08035

Spain

Institut Catala d'Oncologia (ICO)

Barcelona, 8908

Spain

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

Barcelona, 8916

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, 500

Taiwan

National Cheng-Kung University Hospital

Tainan, 70403

Taiwan

National Taiwan University Hospital (NTUH)

Taipei, 10002

Taiwan

National Taiwan University Cancer Center

Taipei, 106

Taiwan

Queen Elizabeth Hospital

Birmingham, B152TH

United Kingdom

University Hospital of Wales, Cardiff

Cardiff, CF14 4XW

United Kingdom

Queen Elizabeth University Hospital

Glasgow, G514TF

United Kingdom

University College Hospital,

London, NW1 2BU

United Kingdom

Imperial College, London

London,

United Kingdom

Manchester Royal Infirmary;Manchester University

Manchester, M139WL

United Kingdom

Newcastle Upon Tyne Hospitals Norhtern Center for Cancer Care

Newcastle upon Tyne, NE7 7DN

United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB

United Kingdom

Oxford University Hospitals

Oxford,

United Kingdom

Royal Hallamshire Hospital

Sheffield, S10 2JF

United Kingdom