New drug aims to keep AML away after transplant

NCT ID NCT05429632

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether mocravimod, taken as a pill, can prevent acute myeloid leukemia (AML) from returning after a stem cell transplant. About 366 adults with high-risk AML will receive either mocravimod or a placebo for up to two years. The main goal is to see if the drug improves relapse-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mocravimod
What this could lead to
If it works, mocravimod could help prevent AML from coming back after a stem cell transplant, improving long-term survival.
What could go wrong
This is still an experimental drug. Even in this large Phase 3 trial, it may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 366 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    68 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anjo-kosei Hospital

    WITHDRAWN

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

  • Apteka NSSU

    WITHDRAWN

    Krakow, 31-501, Poland

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

    WITHDRAWN

    Alessandria, 15121, Italy

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    RECRUITING

    Pesaro, 61122, Italy

  • Azienda Ospedaliera San Gerardo - Monza

    RECRUITING

    Monza, 20900, Italy

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

    ACTIVE_NOT_RECRUITING

    Ascoli Piceno, 63100, Italy

  • Azienda Sanitaria Localedella provincia di Brindisi -

    WITHDRAWN

    Brindisi, Brindisi, 72100, Italy

  • Banner MD Anderson Cancer Center

    WITHDRAWN

    Gilbert, Arizona, 85234-2165, United States

  • Baylor Charles A. Sammons Cancer Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • CEPON - Centro de Pesquisas Oncologicas

    WITHDRAWN

    Florianópolis, Santa Catarina, 88034-000, Brazil

  • CHRU Nancy Hopitaux de Brabois

    RECRUITING

    Nancy, France

  • CHU de Nantes - Hôtel Dieu

    ACTIVE_NOT_RECRUITING

    Nantes, France

  • Centralny Szpital Kliniczny Apteka Szpitalna

    RECRUITING

    Warsaw, 02-097, Poland

  • Centre Hospitalier Lyon-Sud

    RECRUITING

    Lyon, 69495, France

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

    ACTIVE_NOT_RECRUITING

    Lille, France

  • Centre Hospitalier Universitaire (CHU) Angers

    RECRUITING

    Angers, France

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

    RECRUITING

    Villejuif, France

  • Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC

    RECRUITING

    Buenos Aires, Argentina

  • Changhua Christian Hospital

    WITHDRAWN

    Changhua, 500, Taiwan

  • City of Hope Comprehensive Cancer Center - Duarte

    RECRUITING

    Duarte, California, 91010, United States

  • Ehime Prefectural Centeral Hospital, Ehime

    WITHDRAWN

    Matsuyama, 790-0024, Japan

  • Emory University - Winship Cancer Institute (WCI)

    RECRUITING

    Atlanta, Georgia, 30322-1013, United States

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Italy

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, 27100, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, Roma, 00168, Italy

  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli

    RECRUITING

    Reggio Calabria, Calabria, 89133, Italy

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, Israel

  • Henry Ford Cancer Institute

    RECRUITING

    Detroit, Michigan, 48202-2610, United States

  • Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital

    ACTIVE_NOT_RECRUITING

    Hiroshima, 730-8619, Japan

  • Hokkaido University Hospital

    RECRUITING

    Sapporo, 060-8648, Japan

  • Hospital Alemao Oswaldo Cruz (HAOC)

    RECRUITING

    São Paulo, 01327-001, Brazil

  • Hospital Amaral Carvalho

    RECRUITING

    São Paulo, 17210-080, Brazil

  • Hospital Clinico Universitario - Universidad de Salamanca

    RECRUITING

    Salamanca, Spain

  • Hospital De La Princesa

    WITHDRAWN

    Madrid, Spain

  • Hospital El Cruce - Dr. Nestor Kirchner

    RECRUITING

    Buenos Aires, B1884LAD, Argentina

  • Hospital Erasto Gaertner

    RECRUITING

    Curicica, 81520-060, Brazil

  • Hospital Israelita Albert Einstein

    ACTIVE_NOT_RECRUITING

    São Paulo, 05652-900, Brazil

  • Hospital Italiano La Plata

    RECRUITING

    La Plata, 1900, Argentina

  • Hospital Saint Antoine

    RECRUITING

    Paris, France

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

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Virgen de las Nieves

    RECRUITING

    Granada, Spain

  • Hospital Universitario de Gran Canaria ""

    RECRUITING

    Las Palmas de Gran Canaria, Spain

  • Hôpital Saint Louis

    ACTIVE_NOT_RECRUITING

    Paris, France

  • Imperial College, London

    ACTIVE_NOT_RECRUITING

    London, United Kingdom

  • Institut Catala d'Oncologia (ICO)

    RECRUITING

    Barcelona, 8908, Spain

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

    WITHDRAWN

    Barcelona, 8916, Spain

  • Institut Universitaire du Cancer de Toulouse Oncopole

    ACTIVE_NOT_RECRUITING

    Toulouse, 31059, France

  • Institutul Clinic Fundeni

    RECRUITING

    Bucharest, 022328, Romania

  • Institutul Regional de Oncologie Iasi, - Haematology Department

    WITHDRAWN

    Iași, 700483, Romania

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

    ACTIVE_NOT_RECRUITING

    San Giovanni Rotondo, Foggia, 71013, Italy

  • Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)

    RECRUITING

    Nagoya, Aichi-ken, 466-8550, Japan

  • Jichi Medical University (JMU) Hospital

    WITHDRAWN

    Shimotsuke-shi, Tochigi, 329-0498, Japan

  • Jichi Medical University Saitama Medical Center

    WITHDRAWN

    Saitama, Saitama, 330-8503, Japan

  • Kanazawa University Hospital

    WITHDRAWN

    Kanazawa, Ishikawa-ken, 920-8541, Japan

  • Kobe City Medical Center General Hospital

    ACTIVE_NOT_RECRUITING

    Kobe, 650-0047, Japan

  • Kyoto University Hospital

    ACTIVE_NOT_RECRUITING

    Kōtoku, 606-8507, Japan

  • Kyushu University Hospital,

    RECRUITING

    Fukuoka, 812-8582, Japan

  • LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen

    ACTIVE_NOT_RECRUITING

    Munich, 81377, Germany

  • Manchester Royal Infirmary;Manchester University

    RECRUITING

    Manchester, M139WL, United Kingdom

  • Massachusetts General Hospital

    WITHDRAWN

    Boston, Massachusetts, 02114, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • National Cheng-Kung University Hospital

    WITHDRAWN

    Tainan, 70403, Taiwan

  • National Taiwan University Cancer Center

    RECRUITING

    Taipei, 106, Taiwan

  • National Taiwan University Hospital (NTUH)

    RECRUITING

    Taipei, 10002, Taiwan

  • Newcastle Upon Tyne Hospitals Norhtern Center for Cancer Care

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Nottingham University Hospitals NHS Trust

    ACTIVE_NOT_RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Ochsner Medical Center (OMC) - New Orleans

    WITHDRAWN

    New Orleans, Louisiana, 70121, United States

  • Oita University (OU) Hospital

    WITHDRAWN

    Yufu, 875593, Japan

  • Okayama University Hospital

    ACTIVE_NOT_RECRUITING

    Okayama, 700-8558, Japan

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

    RECRUITING

    Portland, Oregon, 97239-3098, United States

  • Osaka Metropolitan University Hospital

    RECRUITING

    Osaka, Osaka, 545-8589, Japan

  • Ospedale Vito Fazzi Lecce

    RECRUITING

    Lecce, Lecce, 73100, Italy

  • Oxford University Hospitals

    RECRUITING

    Oxford, United Kingdom

  • Queen Elizabeth Hospital

    RECRUITING

    Birmingham, B152TH, United Kingdom

  • Queen Elizabeth University Hospital

    RECRUITING

    Glasgow, G514TF, United Kingdom

  • Rambam Health Care Campus

    RECRUITING

    Haifa, Israel

  • Royal Hallamshire Hospital

    RECRUITING

    Sheffield, S10 2JF, United Kingdom

  • Sanatorio Allende (SA) - Nueva Cordoba

    WITHDRAWN

    Córdoba, Argentina

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

    ACTIVE_NOT_RECRUITING

    Katowice, Silesian Voivodeship, Silesia, Poland

  • Sp Zoz Szpital Uniwersytecki W Krakowie

    WITHDRAWN

    Krakow, Aichi-Ken, 30-688, Poland

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

    ACTIVE_NOT_RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Spitalul Clinic Coltea

    WITHDRAWN

    Bucharest, Romania

  • Stony Brook University (SBU) - Cancer Center

    ACTIVE_NOT_RECRUITING

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

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

    NOT_YET_RECRUITING

    Strasbourg, France

  • The Chaim Sheba Medical Center

    RECRUITING

    Tel Litwinsky, Israel

  • The Ohio State University Comprehensive Cancer Center (OSUCCC)

    RECRUITING

    Cleveland, Ohio, 44106-1716, United States

  • The Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, Israel

  • Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital

    ACTIVE_NOT_RECRUITING

    Tokyo, Japan

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

    WITHDRAWN

    Aurora, Colorado, 80045, United States

  • Unicamp

    RECRUITING

    São Paulo, 13083-878, Brazil

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

    RECRUITING

    São Paulo, 05403-000, Brazil

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

    RECRUITING

    Florence, Italy

  • Universitaetsklinikum Jena - Klinik fuer Innere Medizin II

    WITHDRAWN

    Jena, 07747, Germany

  • Universitaetsspital Basel

    RECRUITING

    Basel, Switzerland

  • University College Hospital,

    RECRUITING

    London, NW1 2BU, United Kingdom

  • University Hospital of Wales, Cardiff

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • University of Alabama Hospital (UAB Hospital)

    ACTIVE_NOT_RECRUITING

    Birmingham, Alabama, 35233-1932, United States

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

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Cincinnati Medical Center (University Hospital)

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66103, United States

  • University of Leipzig Medical Center

    ACTIVE_NOT_RECRUITING

    Leipzig, 04103, Germany

  • University of Maryland Medical Center (UMMC)

    RECRUITING

    Baltimore, Maryland, 21201-1544, United States

  • University of Pennsylvania - Abramson Cancer Center

    SUSPENDED

    Philadelphia, Pennsylvania, 19104-4206, United States

  • University of Rochester Medical Center (URMC)

    RECRUITING

    Rochester, New York, 14642, United States

  • Universitätsklinikum Freiburg

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitätsklinikum Halle

    RECRUITING

    Halle, Germany

  • Uniwersyteckie Centrum Kliniczne (UCK)

    RECRUITING

    Gdansk, 80-952, Poland

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