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

June 11, 2026 updated by: Priothera SAS

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

366

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1884LAD
      • Buenos Aires, Argentina
        • Recruiting
        • Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC
        • Contact:
      • Córdoba, Argentina
        • Withdrawn
        • Sanatorio Allende (SA) - Nueva Cordoba
      • La Plata, Argentina, 1900
  • Brazil
      • Curicica, Brazil, 81520-060
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)
        • Contact:
      • São Paulo, Brazil, 01327-001
        • Recruiting
        • Hospital Alemao Oswaldo Cruz (HAOC)
        • Contact:
      • São Paulo, Brazil, 05652-900
        • Active, not recruiting
        • Hospital Israelita Albert Einstein
      • São Paulo, Brazil, 13083-878
        • Recruiting
        • Unicamp
        • Contact:
      • São Paulo, Brazil, 17210-080
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88034-000
        • Withdrawn
        • CEPON - Centro de Pesquisas Oncologicas
  • France
      • Angers, France
      • Lille, France
        • Active, not recruiting
        • Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez -
      • Lyon, France, 69495
      • Nantes, France
        • Active, not recruiting
        • CHU de Nantes - Hôtel Dieu
      • Paris, France
      • Paris, France
        • Active, not recruiting
        • Hôpital Saint Louis
      • Toulouse, France, 31059
        • Active, not recruiting
        • Institut Universitaire du Cancer de Toulouse Oncopole
      • Villejuif, France
  • Germany
      • Halle, Germany
      • Jena, Germany, 07747
        • Withdrawn
        • Universitaetsklinikum Jena - Klinik fuer Innere Medizin II
      • Leipzig, Germany, 04103
      • Munich, Germany, 81377
        • Active, not recruiting
        • LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen
  • Israel
  • Italy
      • Alessandria, Italy, 15121
        • Withdrawn
        • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
      • Ascoli Piceno, Italy, 63100
        • Active, not recruiting
        • Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno
      • Brindisi, Italy, 72100
        • Withdrawn
        • Azienda Sanitaria Localedella provincia di Brindisi -
      • Florence, Italy
        • Recruiting
        • Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMO
        • Contact:
      • Lecce, Italy, 73100
      • Milan, Italy
      • Monza, Italy, 20900
      • Pavia, Italy, 27100
      • Pesaro, Italy, 61122
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
    • Calabria
      • Reggio Calabria, Calabria, Italy, 89133
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Active, not recruiting
        • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
  • Japan
      • Fukuoka, Japan, 812-8582
      • Hiroshima, Japan, 730-8619
        • Recruiting
        • Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital
        • Contact:
      • Kobe, Japan, 650-0047
        • Recruiting
        • Kobe City Medical Center General Hospital
        • Contact:
      • Kōtoku, Japan, 606-8507
      • Matsuyama, Japan, 790-0024
        • Withdrawn
        • Ehime Prefectural Centeral Hospital, Ehime
      • Okayama, Japan, 700-8558
      • Saitama, Japan, 330-8503
        • Withdrawn
        • Jichi Medical University Saitama Medical Center
      • Sapporo, Japan, 060-8648
      • Tokyo, Japan
        • Recruiting
        • Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital
        • Contact:
      • Yufu, Japan, 875593
        • Withdrawn
        • Oita University (OU) Hospital
    • Aichi-ken
      • Anjo-shi, Aichi-ken, Japan, 446-8602
        • Withdrawn
        • Anjo-kosei Hospital
      • Nagoya, Aichi-ken, Japan, 466-8550
        • Recruiting
        • Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)
        • Contact:
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8541
        • Withdrawn
        • Kanazawa University Hospital
    • Osaka
      • Osaka, Osaka, Japan, 545-8589
        • Recruiting
        • Osaka Metropolitan University Hospital
        • Contact:
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan, 329-0498
        • Withdrawn
        • Jichi Medical University (JMU) Hospital
  • Poland
      • Gdansk, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne (UCK)
        • Contact:
      • Krakow, Poland, 31-501
        • Withdrawn
        • Apteka NSSU
      • Warsaw, Poland, 02-097
    • Aichi-Ken
      • Krakow, Aichi-Ken, Poland, 30-688
        • Withdrawn
        • Sp Zoz Szpital Uniwersytecki W Krakowie
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, Silesia
        • Active, not recruiting
        • Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) - Slaskie Centrum Hematologii I Transplantacji Szpiku
  • Romania
      • Bucharest, Romania, 022328
      • Bucharest, Romania
        • Withdrawn
        • Spitalul Clinic Coltea
      • Iași, Romania, 700483
        • Withdrawn
        • Institutul Regional de Oncologie Iasi, - Haematology Department
  • Spain
      • Barcelona, Spain, 8908
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
        • Contact:
      • Barcelona, Spain, 8916
        • Withdrawn
        • Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location
      • Granada, Spain
      • Las Palmas de Gran Canaria, Spain
        • Recruiting
        • Hospital Universitario de Gran Canaria ""
        • Contact:
      • Madrid, Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
      • Madrid, Spain
        • Withdrawn
        • Hospital De La Princesa
      • Salamanca, Spain
        • Recruiting
        • Hospital Clinico Universitario - Universidad de Salamanca
        • Contact:
      • Valencia, Spain
        • Recruiting
        • Hospital Universitari i Politècnic La Fe
        • Contact:
  • Switzerland
  • Taiwan
      • Changhua, Taiwan, 500
        • Withdrawn
        • Changhua Christian Hospital
      • Tainan, Taiwan, 70403
        • Withdrawn
        • National Cheng-Kung University Hospital
      • Taipei, Taiwan, 106
        • Recruiting
        • National Taiwan University Cancer Center
        • Contact:
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital (NTUH)
        • Contact:
  • United Kingdom
      • Birmingham, United Kingdom, B152TH
      • Cardiff, United Kingdom, CF14 4XW
      • Glasgow, United Kingdom, G514TF
      • London, United Kingdom, NW1 2BU
      • London, United Kingdom
        • Active, not recruiting
        • Imperial College, London
      • Manchester, United Kingdom, M139WL
        • Recruiting
        • Manchester Royal Infirmary;Manchester University
        • Contact:
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • Newcastle Upon Tyne Hospitals Norhtern Center for Cancer Care
        • Contact:
      • Nottingham, United Kingdom, NG5 1PB
        • Active, not recruiting
        • Nottingham University Hospitals NHS Trust
      • Oxford, United Kingdom
      • Sheffield, United Kingdom, S10 2JF
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-1932
        • Active, not recruiting
        • University of Alabama Hospital (UAB Hospital)
    • Arizona
      • Gilbert, Arizona, United States, 85234-2165
        • Withdrawn
        • Banner MD Anderson Cancer Center
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center - Duarte
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles (UCLA) - David Geffen School of Medicine
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Withdrawn
        • UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
    • Florida
      • Tampa, Florida, United States, 33612
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Recruiting
        • Emory University - Winship Cancer Institute (WCI)
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Westwood, Kansas, United States, 66103
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Withdrawn
        • Ochsner Medical Center (OMC) - New Orleans
    • Maryland
      • Baltimore, Maryland, United States, 21201-1544
        • Recruiting
        • University of Maryland Medical Center (UMMC)
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Withdrawn
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202-2610
        • Recruiting
        • Henry Ford Cancer Institute
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
        • Active, not recruiting
        • Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)
    • New York
      • Rochester, New York, United States, 14642
      • Stony Brook, New York, United States, 11794-0001
        • Active, not recruiting
        • Stony Brook University (SBU) - Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati Medical Center (University Hospital)
        • Contact:
      • Cleveland, Ohio, United States, 44106-1716
        • Recruiting
        • The Ohio State University Comprehensive Cancer Center (OSUCCC)
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Recruiting
        • Oregon Health & Science University (OHSU) - Knight Cancer Institute
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4206
        • Suspended
        • University of Pennsylvania - Abramson Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3mg mocravimod arm
3 mg of mocravimod orally once per day for 12 months
Drug: mocravimod
S1PR modulator
Experimental: 1mg mocravimod arm
1 mg of mocravimod orally once per day for 12 months
Drug: mocravimod
S1PR modulator
Placebo Comparator: Placebo arm
placebo orally once per day for 12 months
Drug: mocravimod
S1PR modulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse-free survival (RFS)
Time Frame: 12 months
To compare the efficacy of mocravimod to that of placebo
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 24 months
To compare mocravimod's effect on overall survival (OS) to that of placebo
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Priothera SAS

Investigators

  • Principal Investigator: Marcos DeLima, MD, The Ohio State University Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Priothera SAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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