Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT05429632

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

Led by Priothera SAS · Updated on 2026-05-14

366

Participants Needed

108

Research Sites

385 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of AML (excluding acute promyelocytic leukemia) according to WHO 2022 classification
  • European Leukemia Net (ELN) high-risk or intermediate-risk AML in first complete remission (CR1), or AML of any risk in second complete remission (CR2), with CRi also allowed
  • 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) greater than or equal to 1.5
  • Planned use of tacrolimus (TAC)-based graft-versus-host disease (GvHD) prophylaxis
  • Age between 18 and 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Not Eligible

You will not qualify if you...

  • Use of cyclosporine A (CsA), anti-thymocyte globulin (ATG), alemtuzumab, or abatacept for GvHD prophylaxis
  • Diagnosis of macular edema during screening
  • Cardiac, pulmonary, hepatic, or renal dysfunction
  • Hepatic dysfunction defined as AST and/or ALT greater than 2.5 times the upper limit of normal, or total bilirubin greater than 1.5 mg/dL
  • Renal dysfunction with estimated creatinine clearance less than 45 mL/min by Cockcroft-Gault formula
  • Diabetes mellitus
  • History or presence of uveitis at screening
  • History or diagnosis of macular edema

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 108 locations

1

University of Alabama Hospital (UAB Hospital)

Birmingham, Alabama, United States, 35233-1932

Actively Recruiting

2

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234-2165

Withdrawn

3

City of Hope Comprehensive Cancer Center - Duarte

Duarte, California, United States, 91010

Actively Recruiting

4

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

Los Angeles, California, United States, 90095

Actively Recruiting

5

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

Aurora, Colorado, United States, 80045

Withdrawn

6

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

7

Emory University - Winship Cancer Institute (WCI)

Atlanta, Georgia, United States, 30322-1013

Actively Recruiting

8

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

Actively Recruiting

9

University of Kansas Cancer Center

Westwood, Kansas, United States, 66103

Actively Recruiting

10

Ochsner Medical Center (OMC) - New Orleans

New Orleans, Louisiana, United States, 70121

Withdrawn

11

University of Maryland Medical Center (UMMC)

Baltimore, Maryland, United States, 21201-1544

Actively Recruiting

12

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Withdrawn

13

Henry Ford Cancer Institute

Detroit, Michigan, United States, 48202-2610

Actively Recruiting

14

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

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

15

University of Rochester Medical Center (URMC)

Rochester, New York, United States, 14642

Actively Recruiting

16

Stony Brook University (SBU) - Cancer Center

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

Actively Recruiting

17

University of Cincinnati Medical Center (University Hospital)

Cincinnati, Ohio, United States, 45267

Actively Recruiting

18

The Ohio State University Comprehensive Cancer Center (OSUCCC)

Cleveland, Ohio, United States, 44106-1716

Actively Recruiting

19

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

Portland, Oregon, United States, 97239-3098

Actively Recruiting

20

University of Pennsylvania - Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104-4206

Suspended

21

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States, 75246

Actively Recruiting

22

Hospital El Cruce - Dr. Nestor Kirchner

Buenos Aires, Argentina, B1884LAD

Actively Recruiting

23

Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC

Buenos Aires, Argentina

Actively Recruiting

24

Sanatorio Allende (SA) - Nueva Cordoba

Córdoba, Argentina

Actively Recruiting

25

Hospital Italiano La Plata

La Plata, Argentina, 1900

Actively Recruiting

26

CEPON - Centro de Pesquisas Oncologicas

Florianópolis, Santa Catarina, Brazil, 88034-000

Actively Recruiting

27

Hospital Erasto Gaertner

Curicica, Brazil, 81520-060

Actively Recruiting

28

Hospital Alemao Oswaldo Cruz (HAOC)

São Paulo, Brazil, 01327-001

Actively Recruiting

29

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

São Paulo, Brazil, 05403-000

Actively Recruiting

30

Hospital Israelita Albert Einstein

São Paulo, Brazil, 05652-900

Actively Recruiting

31

Unicamp

São Paulo, Brazil, 13083-878

Actively Recruiting

32

Hospital Amaral Carvalho

São Paulo, Brazil, 17210-080

Actively Recruiting

33

Centre Hospitalier Universitaire (CHU) Angers

Angers, France

Actively Recruiting

34

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

Lille, France

Actively Recruiting

35

Centre Hospitalier Lyon-Sud

Lyon, France, 69495

Actively Recruiting

36

CHU de Nantes - Hôtel Dieu

Nantes, France

Actively Recruiting

37

Hospital Saint Antoine

Paris, France

Actively Recruiting

38

Hôpital Saint Louis

Paris, France

Actively Recruiting

39

Institut Universitaire du Cancer de Toulouse Oncopole

Toulouse, France, 31059

Actively Recruiting

40

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

Villejuif, France

Actively Recruiting

41

Universitätsklinikum Halle

Halle, Germany

Actively Recruiting

42

Universitaetsklinikum Jena - Klinik fuer Innere Medizin II

Jena, Germany, 07747

Withdrawn

43

University of Leipzig Medical Center

Leipzig, Germany, 04103

Actively Recruiting

44

LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen

Munich, Germany, 81377

Active, Not Recruiting

45

Rambam Health Care Campus

Haifa, Israel

Actively Recruiting

46

Hadassah Medical Center

Jerusalem, Israel

Actively Recruiting

47

The Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Actively Recruiting

48

The Chaim Sheba Medical Center

Tel Litwinsky, Israel

Actively Recruiting

49

Grande Ospedale Metropolitano Bianchi Melacrino Morelli

Reggio Calabria, Calabria, Italy, 89133

Actively Recruiting

50

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

San Giovanni Rotondo, Foggia, Italy, 71013

Actively Recruiting

51

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

Alessandria, Italy, 15121

Withdrawn

52

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

Ascoli Piceno, Italy, 63100

Actively Recruiting

53

Azienda Sanitaria Localedella provincia di Brindisi -

Brindisi, Italy, 72100

Withdrawn

54

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

Florence, Italy

Actively Recruiting

55

Ospedale Vito Fazzi Lecce

Lecce, Italy, 73100

Actively Recruiting

56

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

Actively Recruiting

57

Azienda Ospedaliera San Gerardo - Monza

Monza, Italy, 20900

Actively Recruiting

58

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Actively Recruiting

59

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, Italy, 61122

Actively Recruiting

60

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

Actively Recruiting

61

Anjo-kosei Hospital

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

Withdrawn

62

Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)

Nagoya, Aichi-ken, Japan, 466-8550

Actively Recruiting

63

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan, 920-8541

Withdrawn

64

Osaka Metropolitan University Hospital

Osaka, Osaka, Japan, 545-8589

Actively Recruiting

65

Jichi Medical University (JMU) Hospital

Shimotsuke-shi, Tochigi, Japan, 329-0498

Withdrawn

66

Kyushu University Hospital,

Fukuoka, Japan, 812-8582

Actively Recruiting

67

Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital

Hiroshima, Japan, 730-8619

Actively Recruiting

68

Kobe City Medical Center General Hospital

Kobe, Japan, 650-0047

Actively Recruiting

69

Kyoto University Hospital

Kōtoku, Japan, 606-8507

Actively Recruiting

70

Ehime Prefectural Centeral Hospital, Ehime

Matsuyama, Japan, 790-0024

Withdrawn

71

Okayama University Hospital

Okayama, Japan, 700-8558

Actively Recruiting

72

Jichi Medical University Saitama Medical Center

Saitama, Japan, 330-8503

Withdrawn

73

Hokkaido University Hospital

Sapporo, Japan, 060-8648

Actively Recruiting

74

Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital

Tokyo, Japan

Actively Recruiting

75

Oita University (OU) Hospital

Yufu, Japan, 875593

Withdrawn

76

Sp Zoz Szpital Uniwersytecki W Krakowie

Krakow, Aichi-Ken, Poland, 30-688

Withdrawn

77

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

Katowice, Silesian Voivodeship, Poland, Silesia

Actively Recruiting

78

Uniwersyteckie Centrum Kliniczne (UCK)

Gdansk, Poland, 80-952

Actively Recruiting

79

Apteka NSSU

Krakow, Poland, 31-501

Withdrawn

80

Centralny Szpital Kliniczny Apteka Szpitalna

Warsaw, Poland, 02-097

Actively Recruiting

81

Institutul Clinic Fundeni

Bucharest, Romania, 022328

Actively Recruiting

82

Spitalul Clinic Coltea

Bucharest, Romania

Withdrawn

83

Institutul Regional de Oncologie Iasi, - Haematology Department

Iași, Romania, 700483

Withdrawn

84

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

Barcelona, Spain, 08035

Actively Recruiting

85

Institut Catala d'Oncologia (ICO)

Barcelona, Spain, 8908

Actively Recruiting

86

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

Barcelona, Spain, 8916

Withdrawn

87

Hospital Universitario Virgen de las Nieves

Granada, Spain

Actively Recruiting

88

Hospital Universitario de Gran Canaria ""

Las Palmas de Gran Canaria, Spain

Actively Recruiting

89

Hospital De La Princesa

Madrid, Spain

Withdrawn

90

Hospital Universitario 12 de Octubre

Madrid, Spain

Actively Recruiting

91

Hospital Universitario Ramon y Cajal

Madrid, Spain

Actively Recruiting

92

Hospital Clinico Universitario - Universidad de Salamanca

Salamanca, Spain

Actively Recruiting

93

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Actively Recruiting

94

Universitaetsspital Basel

Basel, Switzerland

Actively Recruiting

95

Changhua Christian Hospital

Changhua, Taiwan, 500

Actively Recruiting

96

National Cheng-Kung University Hospital

Tainan, Taiwan, 70403

Withdrawn

97

National Taiwan University Hospital (NTUH)

Taipei, Taiwan, 10002

Actively Recruiting

98

National Taiwan University Cancer Center

Taipei, Taiwan, 106

Actively Recruiting

99

Queen Elizabeth Hospital

Birmingham, United Kingdom, B152TH

Actively Recruiting

100

University Hospital of Wales, Cardiff

Cardiff, United Kingdom, CF14 4XW

Actively Recruiting

101

Queen Elizabeth University Hospital

Glasgow, United Kingdom, G514TF

Actively Recruiting

102

University College Hospital,

London, United Kingdom, NW1 2BU

Actively Recruiting

103

Imperial College, London

London, United Kingdom

Actively Recruiting

104

Manchester Royal Infirmary;Manchester University

Manchester, United Kingdom, M139WL

Actively Recruiting

105

Newcastle Upon Tyne Hospitals Norhtern Center for Cancer Care

Newcastle upon Tyne, United Kingdom, NE7 7DN

Actively Recruiting

106

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom, NG5 1PB

Actively Recruiting

107

Oxford University Hospitals

Oxford, United Kingdom

Actively Recruiting

108

Royal Hallamshire Hospital

Sheffield, United Kingdom, S10 2JF

Actively Recruiting

Loading map...

Research Team

M

Malika Souquieres, MSc

CONTACT

J

Jens Hasskarl, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here