Adult Acute Myeloid LeukemiaPhase 3MO-TRANSNCT05429632
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
A Phase 3 study testing mocravimod in people with Adult Acute Myeloid Leukemia, run by Priothera SAS at 111 sites in 14 countries.
Trial summary
This is a multi-center, randomized, double-blinded, placebo controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adult Acute Myeloid Leukemia
- What is being tested?
- mocravimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 111 sitesin 14 countries
- Study dates
- 16 Jun 2022to Nov 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
111 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
111 sites in 14 countries
United States21 sites, 13 recruiting
- Recruiting
Emory University - Winship Cancer Institute (WCI)
Atlanta, Georgia, 30322-1013
Edmund Waller, MD, ewaller@emory.edu
- Withdrawn
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
Aurora, Colorado, 80045
- Recruiting
University of Maryland Medical Center (UMMC)
Baltimore, Maryland, 21201-1544
Jean Yared, MD, jyared@umm.edu
- Active, not recruiting
University of Alabama Hospital (UAB Hospital)
Birmingham, Alabama, 35233-1932
- Withdrawn
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
University of Cincinnati Medical Center (University Hospital)
Cincinnati, Ohio, 45267
Edward Faber, MD, 513-584-4268, fabered@ucmail.uc.edu
- Recruiting
The Ohio State University Comprehensive Cancer Center (OSUCCC)
Cleveland, Ohio, 44106-1716
Sarah Wall, MD, sarah.wall@uhhospitals.org
- Recruiting
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Jane Reynolds, MD, Jana.Reynolds@BSWHealth.org
- Recruiting
Henry Ford Cancer Institute
Detroit, Michigan, 48202-2610
Shatha Farhan, MD, sfarhan1@hfhs.org
- Recruiting
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, 91010
Vaibhav Agrawal, MD, vagrawal@coh.org
- Withdrawn
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234-2165
- Active, not recruiting
Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)
Grand Rapids, Michigan, 49503
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Kittika Poonsombudlert, MD, kittika-poonsombudlert@uiowa.edu
- Recruiting
University of California Los Angeles (UCLA) - David Geffen School of Medicine
Los Angeles, California, 90095
Steven Tsai, MD, sctsai@mednet.ucla.edu
- Withdrawn
Ochsner Medical Center (OMC) - New Orleans
New Orleans, Louisiana, 70121
- Suspended
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, 19104-4206
- Recruiting
Oregon Health & Science University (OHSU) - Knight Cancer Institute
Portland, Oregon, 97239-3098
Arpita Gandhi, MD, gandhiar@ohsu.edu
- Recruiting
University of Rochester Medical Center (URMC)
Rochester, New York, 14642
Eric Huselton, MD, Eric_Huselton@URMC.Rochester.edu
- Active, not recruiting
Stony Brook University (SBU) - Cancer Center
Stony Brook, New York, 11794-0001
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Asmita Mishra, MD, asmita.mishra@moffitt.org
- Recruiting
University of Kansas Cancer Center
Westwood, Kansas, 66103
Haitham Abdelhakim, MD, habdelhakim@kumc.edu
Japan15 sites, 4 recruiting
- Withdrawn
Anjo-kosei Hospital
Anjo-shi, Aichi-ken, 446-8602
- Recruiting
Kyushu University Hospital,
Fukuoka, 812-8582
Koji Kato, MD, kojikato@intmed1.med.kyushu-u.ac.jp
- Active, not recruiting
Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital
Hiroshima, 730-8619
- Withdrawn
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8541
- Active, not recruiting
Kobe City Medical Center General Hospital
Kobe, 650-0047
- Active, not recruiting
Kyoto University Hospital
Kōtoku, 606-8507
- Withdrawn
Ehime Prefectural Centeral Hospital, Ehime
Matsuyama, 790-0024
- Recruiting
Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)
Nagoya, Aichi-ken, 466-8550
Tetsuya Nishida, MD, tnishida@med.nagoya-u.ac.jp
- Active, not recruiting
Okayama University Hospital
Okayama, 700-8558
- Recruiting
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8589
Mitsutaka Nishimoto, MD, +81 (0) 6-6645-2121;, nishimo@omu.ac.jp
MD
- Withdrawn
Jichi Medical University Saitama Medical Center
Saitama, 330-8503
- Recruiting
Hokkaido University Hospital
Sapporo, 060-8648
Daigo Hashimoto, d5hash@pop.med.hokudai.ac.jp
- Withdrawn
Jichi Medical University (JMU) Hospital
Shimotsuke-shi, Tochigi, 329-0498
- Active, not recruiting
Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital
Tokyo
- Withdrawn
Oita University (OU) Hospital
Yufu, 875593
Italy12 sites, 8 recruiting
- Withdrawn
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
Alessandria, 15121
- Active, not recruiting
Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno
Ascoli Piceno, 63100
- Withdrawn
Azienda Sanitaria Localedella provincia di Brindisi -
Brindisi, 72100
- Recruiting
Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMO
Florence
Riccardo Saccardi, MD, riccardo.saccardi@aouc.unifi.it
- Recruiting
Ospedale Vito Fazzi Lecce
Lecce, 73100
Nicola Di Renzo, MD, direnzo.ematolecce@gmail.com
- Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan
Giorgia Saporiti, MD, giorgia.saporiti@policlinico.mi.it
- Recruiting
Azienda Ospedaliera San Gerardo - Monza
Monza, 20900
Elisabetta Terruzzi, MD, e.terruzzi@asst-monza.it
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Nicola Polverelli, MD, n.polverelli@smatteo.pv.it
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, 61122
Barbara Guiducci, MD, barbara.guiducci@sanita.marche.it
- Recruiting
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, Calabria, 89133
Maria C Mico, MD, mariacaterina.mico@ospedalerc.it
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Simona Sica, MD, simona.sica@unicatt.it
- Active, not recruiting
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
San Giovanni Rotondo, Foggia, 71013
France10 sites, 6 recruiting
- Recruiting
Centre Hospitalier Universitaire (CHU) Angers
Angers
Sylvain Thepot, MD, Sylvain.Thepot@chu-angers.fr
- Active, not recruiting
Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez -
Lille
- Recruiting
Centre Hospitalier Lyon-Sud
Lyon, 69495
Mael Heiblig, MD, mael.heiblig@chu-lyon.fr
- Recruiting
CHRU Nancy Hopitaux de Brabois
Nancy
Simona Pagliuca, MD, s.pagliuca@chru-nancy.fr
- Active, not recruiting
CHU de Nantes - Hôtel Dieu
Nantes
- Recruiting
Hospital Saint Antoine
Paris
Florent Mallard, MD, florent.malard@inserm.fr
- Active, not recruiting
Hôpital Saint Louis
Paris
- Not yet recruiting
Strasbourg (UIC d'onco-hématologie - Hôpital de Hautepierre)
Strasbourg
Amrooise Marçais, MD, ambroise.marcais@chru-strasbourg.fr
- Active, not recruiting
Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse, 31059
- Recruiting
Centre de Lutte Contre le Cancer (CLCC) - Institut Gustave-Roussy
Villejuif
Cristina Castilla-LLorente, MD
cristina.castilla-llorente@gustaveroussy.fr
Spain10 sites, 8 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Barcelona, 08035
David Valcarcel Ferreiras, MD, dvalcarcel@vhio.net
- Recruiting
Institut Catala d'Oncologia (ICO)
Barcelona, 8908
Annalisa Paviglianiti -surpased, MD, annalisapaviglianiti@iconcologia.net
Marta Pena new PI, MD
- Withdrawn
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location
Barcelona, 8916
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada
Pedro Gonalez-Sierra, MD, Pedroa.gonzalez.sspa@juntadeandalucia.es
- Recruiting
Hospital Universitario de Gran Canaria ""
Las Palmas de Gran Canaria
Melisa Karina Torres Ochando, MD, m.torresochando@gmail.com
- Withdrawn
Hospital De La Princesa
Madrid
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
Maria Calbacho Robles, MD, maria.calbacho@salud.madrid.org
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid
Anabelle Rodriguez_Chinea, MD, anabellechip@hotmail.com
- Recruiting
Hospital Clinico Universitario - Universidad de Salamanca
Salamanca
Estefanía Pérez López, MD, eperezl@saludcastillayleon.es
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia
Joan Montoro Gomez, MD, montoro_jua@gva.es
United Kingdom10 sites, 8 recruiting
- Recruiting
Queen Elizabeth Hospital
Birmingham, B152TH
Maria Maroto, MD, Maria.LosaMoroto@uhb.nhs.uk
- Recruiting
University Hospital of Wales, Cardiff
Cardiff, CF14 4XW
Wendy Ingram, MD, Wendy.ingram@wales.nhs.uk
- Recruiting
Queen Elizabeth University Hospital
Glasgow, G514TF
David Irvine, MD, David.Irvine7@nhs.scot
- Recruiting
University College Hospital,
London, NW1 2BU
Kate Stringaris, MD, kate.stringaris@nhs.net
- Active, not recruiting
Imperial College, London
London
- Recruiting
Manchester Royal Infirmary;Manchester University
Manchester, M139WL
Rahuman Salim, MD, rahuman.salim@mft.nhs.uk
- Recruiting
Newcastle Upon Tyne Hospitals Norhtern Center for Cancer Care
Newcastle upon Tyne, NE7 7DN
Erin Hurst, MD, erin.hurst1@nhs.net
- Active, not recruiting
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
- Recruiting
Oxford University Hospitals
Oxford
Kirsty Sharplin, MD, kirsty.sharplin@ouh.nhs.uk
- Recruiting
Royal Hallamshire Hospital
Sheffield, S10 2JF
Harpreet Knaur, MD, Harpreet.Kaur12@nhs.net
Brazil7 sites, 5 recruiting
- Recruiting
Hospital Erasto Gaertner
Curicica, 81520-060
Joao Samuel de Holanda Farias, MS, jshfarias@erastogaertner.com.br
- Withdrawn
CEPON - Centro de Pesquisas Oncologicas
Florianópolis, Santa Catarina, 88034-000
- Recruiting
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo, 01327-001
Ottavio Baiocchi, MD, obaiocchi@haoc.com.br
- Recruiting
Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)
São Paulo, 05403-000
Gian Carlo Fatobene, MD, giancarlo.fatobene@hc.fm.usp.br
- Active, not recruiting
Hospital Israelita Albert Einstein
São Paulo, 05652-900
- Recruiting
Unicamp
São Paulo, 13083-878
Marcos P Colella, MD, mpc@unicamp.br
- Recruiting
Hospital Amaral Carvalho
São Paulo, 17210-080
Ederson De Mattos, MD, pesquisafac.edersonmattos@gmail.com
Germany5 sites, 2 recruiting
- Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Robert Zeiser, MD, robert.zeiser@uniklinik-freiburg.de
- Recruiting
Universitätsklinikum Halle
Halle
Lutz Mueller, MD, lutz.mueller@uk-halle.de
- Withdrawn
Universitaetsklinikum Jena - Klinik fuer Innere Medizin II
Jena, 07747
- Active, not recruiting
University of Leipzig Medical Center
Leipzig, 04103
- Active, not recruiting
LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen
Munich, 81377
Poland5 sites, 2 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk, 80-952
Agnieszka Piekarska, MD, babajaga@gumed.edu.pl
- Active, not recruiting
Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) - Slaskie Centrum Hematologii I Transplantacji Szpiku
Katowice, Silesian Voivodeship, Silesia
- Withdrawn
Sp Zoz Szpital Uniwersytecki W Krakowie
Krakow, Aichi-Ken, 30-688
- Withdrawn
Apteka NSSU
Krakow, 31-501
- Recruiting
Centralny Szpital Kliniczny Apteka Szpitalna
Warsaw, 02-097
Gregorz Basak, MD, grzegorz.basak@wum.edu.pl
Argentina4 sites, 3 recruiting
- Recruiting
Hospital El Cruce - Dr. Nestor Kirchner
Buenos Aires, B1884LAD
Maria J Dalmaroni, MD, dalmaronijulieta@gmail.com
- Recruiting
Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC
Buenos Aires
Nicolas Cazap, MD, nicaz@yahoo.com
- Withdrawn
Sanatorio Allende (SA) - Nueva Cordoba
Córdoba
- Recruiting
Hospital Italiano La Plata
La Plata, 1900
Sebstian Yantorno, MD, sebastianyantorno@gmail.com
Israel4 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus
Haifa
Tsila Zuckermann, MD, t_zuckerman@rambam.health.gov
- Recruiting
Hadassah Medical Center
Jerusalem
Batia Avni, MD, batiaa@hadassah.org.il
- Recruiting
The Tel Aviv Sourasky Medical Center
Tel Aviv
Ron Ram, MD, ronr@tlvmc.gov.il
- Recruiting
The Chaim Sheba Medical Center
Tel HaShomer
Avichai Shimoni, MD, avichai.Shimoni@sheba.health.gov.il
Taiwan4 sites, 2 recruiting
- Withdrawn
Changhua Christian Hospital
Changhua, 500
- Withdrawn
National Cheng-Kung University Hospital
Tainan, 70403
- Recruiting
National Taiwan University Hospital (NTUH)
Taipei, 10002
Bor Sheng Ko, MD, 2-2312-3456 Ext 63576;, kevinkomd@gmail.com
- Recruiting
National Taiwan University Cancer Center
Taipei, 106
Ko Bor-Sheng, MD, 886 2 2312 3456 x63576, kevinkomd@gmail.com
Romania3 sites
- Withdrawn
Institutul Clinic Fundeni
Bucharest, 022328
- Withdrawn
Spitalul Clinic Coltea
Bucharest
- Withdrawn
Institutul Regional de Oncologie Iasi, - Haematology Department
Iași, 700483
About this study
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
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Read the 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).
- Conditions
- Adult Acute Myeloid Leukemia
- Being tested
- mocravimod
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mocravimodDrug
S1PR modulator
| Study group | Role | What they receive |
|---|---|---|
| 3mg mocravimod arm | Experimental | 3 mg of mocravimod orally once per day for 12 months Receives: Drug: mocravimod |
| 1mg mocravimod arm | Experimental | 1 mg of mocravimod orally once per day for 12 months Receives: Drug: mocravimod |
| Placebo arm | Placebo comparator | placebo orally once per day for 12 months Receives: Drug: mocravimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival (RFS)
To compare the efficacy of mocravimod to that of placebo
Measured: 12 months
Secondary outcomes (1)
Overall survival (OS)
To compare mocravimod's effect on overall survival (OS) to that of placebo
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start16 Jun 2022
- Primary completionMay 2027 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, multicenter, randomized, double-blind, placebo-controlled, and 3-arm parallel group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Priothera SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcos DeLima, MD, Principal investigator, The Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429632
- Sponsor's protocol ID
- Priothera SAS
- Acronym
- MO-TRANS
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05429632
- Acronym / sponsor ID
- MO-TRANS / Priothera SAS
- Conditions
- Adult Acute Myeloid Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Priothera SASIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- prospective, multicenter, randomized, double-blind, placebo-controlled, and 3-arm parallel group study
| Arm | Type | Receives |
|---|---|---|
| 3mg mocravimod arm | Experimental | Drug: mocravimod3 mg of mocravimod orally once per day for 12 months |
| 1mg mocravimod arm | Experimental | Drug: mocravimod1 mg of mocravimod orally once per day for 12 months |
| Placebo arm | Placebo comparator | Drug: mocravimodplacebo orally once per day for 12 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mocravimodS1PR modulator | Drug | 1mg mocravimod arm, 3mg mocravimod arm, Placebo arm |
Primary outcome
Relapse-free survival (RFS)
Time frame: 12 months
To compare the efficacy of mocravimod to that of placebo
1 secondary outcome
Overall survival (OS)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Adult Acute Myeloid Leukemia
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 2
Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 3
Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia
RecruitingPhase 2
Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)
Core Binding Factor Acute Myeloid Leukemia
Enrolling by invitationPhase 1
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring
Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcos DeLima, MD principal investigator
The Ohio State University Comprehensive Cancer Center
111 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mocravimod in people with Adult Acute Myeloid Leukemia, run by Priothera SAS at 111 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in United States, Japan, Italy, France, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malika Souquieres, MSc (+33 (0) 6 40 91 26 76, malika.souquieres@priothera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (RFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.