Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT (MO-TRANS)

Recruiting ID

Official Title

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.

Study Overview

Allogeneic HCT is a standard treatment of curative intent for AML. A major limitation for successful outcome of allogeneic HCT is disease relapse. The Graft-versus-leukemia (GvL) effect is also critical to prevent disease relapse and is mediated by donor T cells contained in the HCT graft that trigger immune responses against leukemic cells.

Mocravimod is an oral S1P receptor (S1PR) modulator that blocks lymphocyte egress from lymphoid organs via its phosphorylated active metabolite. Mocravimod’s potential to preserve the desirable GvL effect while decreasing GvHD is a promising way to maintain the prospect of a cure while decreasing transplant-related mortality (TRM) and morbidity in AML patients undergoing allogeneic HCT.

Study Design

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


The purpose of this pivotal study is to assess the efficacy and safety of mocravimod compared with placebo as an adjunctive and maintenance treatment for allogeneic hematopoietic cell transplantation (HCT) in combination with a standard of care GvHD prophylaxis in adult high-risk AML patients in first complete remission (CR1), intermediate-risk AML patients in CR1 or any AML patients in second complete remission (CR2).

Interested in Participating?

Talk with your doctor or a study investigator if you are interested in taking part in this study. There are other criteria for entry and they will help determine if the trial is right for you.



Males and Females

Healthy Volunteers

Adult Acute Myeloid Leukemia undergoing 1st allogeneic HCT

High or intermediate risk AML in CR1, any risk AML in CR2

Study Details



Study Type

Study Phase
Phase 3

Oral Mocravimod

Priothera SAS


  • 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 CsA-based or TAC-based GvHD prophylaxis
  • age ≥ 18 years and ≤ 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Use of 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

Study locations

The current locations for studies in the US are listed below, and additional locations may be included as they become available. If you do not find a study location in your area, please visit to check if a local study site has been added.
Study Contact
Malika Souquieres, MSc
+33 3 67 51 00 40
Study Contact Backup
Elisabeth Kueenburg, MD
+33 3 67 51 00 40

United States

Alabama Locations

Birmingham, Alabama, United States, 35233-1932
University of Alabama Hospital (UAB Hospital)
Antonio Di Stasi, MD



Arizona Locations

Gilbert, Arizona, United States, 85234-2165
Banner MD Anderson Cancer Center



California Locations

Los Angeles, California, United States, 90095
University of California Los Angeles (UCLA) – David Geffen School of Medicine



Georgia Locations

Atlanta, Georgia, United States, 30322-1013
Emory University – Winship Cancer Institute (WCI)
Edmund Waller, MD



Louisiana Locations

New Orleans, Louisiana, United States, 70121
Ochsner Medical Center (OMC) – New Orleans



Maryland Locations

Baltimore, Maryland, United States, 21201-1544
University of Maryland Medical Center (UMMC)



Michigan Locations

Grand Rapids, Michigan, United States, 49503
Spectrum Health Medical Group (SHMG) – Blood & Marrow Transplant – Adult (BMT)
Sami Brake, MD



New York Locations

Stony Brook, New York, United States, 11794-0001
Stony Brook University (SBU) – Cancer Center
Fengshuo Lan, MD



Ohio Locations

Cincinnati, Ohio, United States, 45267
University of Cincinnati Medical Center (University Hospital)


Cleveland, Ohio, United States, 44106-1716
The Ohio State University Comprehensive Cancer Center (OSUCCC)
Gabriella Pettito, MD



Oregon Locations

Portland, Oregon, United States, 97239-3098
Oregon Health & Science University (OHSU) – Knight Cancer Institute
Arpita Gandhi, MD



Pennsylvania Locations

Philadelphia, Pennsylvania, United States, 19104-4206
University of Pennsylvania – Abramson Cancer Center



Texas Locations

Dallas, Texas, United States, 75246
Baylor Charles A. Sammons Cancer Center


Haifa, Israel
Rambam Health Care Campus
Tsila Zuckermann, MD

Jerusalem, Israel
Hadassah Medical Center

Tel Aviv, Israel
The Tel Aviv Sourasky Medical Center
Ron Ram, MD

Tel HaShomer, Israel
The Chaim Sheba Medical Center
Avichai Shimoni, MD


Bucharest, Romania
Spitalul Clinic Coltea

Iasi, Romania, 700483
Institutul Regional de Oncologie Iasi, – Haematology Department
Angela Dascalescu, MD

United Kingdom

London, United Kingdom
Imperial College, London
Eduardo Olavarria, MD


São Paulo, Brazil, 01327-001
Hospital Alemao Oswaldo Cruz (HAOC)


Halle, Germany
Universitätsklinikum Halle

Jena, Germany, 07747
Universitaetsklinikum Jena – Klinik fuer Innere Medizin II

Leipzig, Germany, 04103
University of Leipzig Medical Center
Georg-Nikolaus Franke, MP
+49 341 97-13132

Munich, Germany, 81377
LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen


Alessandria, Italy, 15121
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria

Ascoli Piceno, Italy, 63100
Azienda Sanitaria Locale 13 – Ospedale “C. e G. Mazzoni”- Ascoli Piceno
Piero Galieni, MD

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

Milano, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Giorgia Saporiti, MD

Monza, Italy, 20900
Azienda Ospedaliera San Gerardo – Monza

Pavia, Italy, 27100
Fondazione IRCCS Policlinico San Matteo

San Giovanni Rotondo, Foggia, Italy, 71013
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) – Ospedale Casa Sollievo della Sofferenza (CSS)


Gdansk, Poland, 80-952
Uniwersyteckie Centrum Kliniczne (UCK)
Agnieszka Piekarska, MD

Katowice, Silesia, Poland, Silesia
Slaski Uniwersytet Medyczny (SUM) w Katowicach – Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) – Slaskie Centrum Hematologii I Transplantacji Szpiku
Agata Wieczorkiewicz-Kabut


Changhua City, Taiwan, 500
Changhua Christian Hospital

Tainan, Taiwan, 70403
National Cheng-Kung University Hospital

Taipei, Taiwan, 10002
National Taiwan University Hospital (NTUH)


Angers, France
Centre Hospitalier Universitaire (CHU) Angers
Sylvain Thepot, MD
Lille, France
Centre Hospitalier Regional Universitaire (CHRU) de Lille – Hopital Claude Huriez
Nantes, France
CHU de Nantes – Hôtel Dieu
Patrice Chevallier, MD
Paris, France
Hospital Saint Antoine
Florent Mallard, MD
Paris, France
Hôpital Saint Louis
Villejuif, France
Centre de Lutte Contre le Cancer (CLCC) – Institut Gustave-Roussy


Kobe-shi, Japan, 650-0047
Kobe City Medical Center General Hospital
Takayuki Ishikawa, MD

Sapporo-shi, Japan, 060-8648
Hokkaido University Hospital

Tokyo, Japan
Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital

Yufu, Japan, 875593
Oita University (OU) Hospital

Osaka-shi, Osaka-Fu, Japan, 545-8589
Osaka Metropolitan University Hospital

Shimotsuke-shi, Tochigi-Ken, Japan, 329-0498
Jichi Medical University (JMU) Hospital


Basel, Switzerland
Universitaetsspital Basel


Barcelona, Spain, 08035
Hospital Universitari Vall d’Hebron – Institut de Recerca (VHIR)

Barcelona, Spain, 8908
Institut Catala d’Oncologia (ICO)
Annalisa Paviglianiti, MD

Barcelona, Spain, 8916
Institut Catala d’Oncologia (ICO) – Hospital Universitari Germans Trias i Pujol (HUGTP) Location

Granada, Spain
Hospital Universitario Virgen de las Nieves
Pedro Gonalez-Sierra, MD

Las Palmas De Gran Canaria, Spain
Hospital Universitario de Gran Canaria “”
Melisa Karina Torres Ochando, MD

Madrid, Spain
Hospital De La Princesa

Madrid, Spain
Hospital Universitario 12 de Octubre
Maria Calbacho Robles, MD

Madrid, Spain
Hospital Universitario Ramon y Cajal

Salamanca, Spain
Hospital Clinico Universitario – Universidad de Salamanca
Estefanía Pérez López, MD

Valencia, Spain
Hospital Universitari i Politecnic La Fe
Jaime Sanz Caballer, MD