NCT05429632Recruiting
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
Summary
This is a multi-center, randomized, double-blinded, placebo controlled trial.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, United States, Argentina, Brazil, Israel, Japan, Poland, Romania, Spain, Taiwan, United Kingdom
- Sponsor
- Priothera SAS(Industry)
- Protocol no.
- Priothera SAS
- Conditions
- Adult Acute Myeloid Leukemia
- Interventions
- Drug
Treatments studied
- mocravimod
Locations · 66
- Basel, SwitzerlandUniversitaetsspital BaselRecruiting at this site
- Angers, FranceCentre Hospitalier Universitaire (CHU) AngersRecruiting at this site
- Lyon, FranceCentre Hospitalier Lyon-SudRecruiting at this site
- Nancy, FranceCHRU Nancy Hopitaux de BraboisRecruiting at this site
- Paris, FranceHospital Saint AntoineRecruiting at this site
- Villejuif, FranceCentre de Lutte Contre le Cancer (CLCC) - Institut Gustave-RoussyRecruiting at this site
- Freiburg im Breisgau, GermanyUniversitätsklinikum FreiburgRecruiting at this site
- Halle, GermanyUniversitätsklinikum HalleRecruiting at this site
- Reggio Calabria, ItalyGrande Ospedale Metropolitano Bianchi Melacrino MorelliRecruiting at this site
- Lecce, ItalyOspedale Vito Fazzi LecceRecruiting at this site
- Roma, ItalyFondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting at this site
- Florence, ItalyUniversita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMORecruiting at this site
- Milan, ItalyFondazione IRCCS Ca Granda Ospedale Maggiore PoliclinicoRecruiting at this site
- Monza, ItalyAzienda Ospedaliera San Gerardo - MonzaRecruiting at this site
- Pavia, ItalyFondazione IRCCS Policlinico San MatteoRecruiting at this site
- Pesaro, ItalyAzienda Ospedaliera Ospedali Riuniti Marche NordRecruiting at this site
- Duarte, United StatesCity of Hope Comprehensive Cancer Center - DuarteRecruiting at this site
- Los Angeles, United StatesUniversity of California Los Angeles (UCLA) - David Geffen School of MedicineRecruiting at this site
- Tampa, United StatesMoffitt Cancer CenterRecruiting at this site
- Atlanta, United StatesEmory University - Winship Cancer Institute (WCI)Recruiting at this site
- Iowa City, United StatesUniversity of Iowa Hospitals and ClinicsRecruiting at this site
- Westwood, United StatesUniversity of Kansas Cancer CenterRecruiting at this site
- Baltimore, United StatesUniversity of Maryland Medical Center (UMMC)Recruiting at this site
- Detroit, United StatesHenry Ford Cancer InstituteRecruiting at this site
- Rochester, United StatesUniversity of Rochester Medical Center (URMC)Recruiting at this site
- Cincinnati, United StatesUniversity of Cincinnati Medical Center (University Hospital)Recruiting at this site
- Cleveland, United StatesThe Ohio State University Comprehensive Cancer Center (OSUCCC)Recruiting at this site
- Portland, United StatesOregon Health & Science University (OHSU) - Knight Cancer InstituteRecruiting at this site
- Dallas, United StatesBaylor Charles A. Sammons Cancer CenterRecruiting at this site
- Buenos Aires, ArgentinaHospital El Cruce - Dr. Nestor KirchnerRecruiting at this site
In total, worldwide, 66 of the 111 sites listed in the registry are recruiting; the other 45 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: July 17, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 36 more locations
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.