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Clinical Trials in the UK / NCT05429632
Recruiting Phase 3

Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

NCT05429632 · tracked via the Priya Life Science UK tracker
Sponsor
Priothera SAS
Phase
Phase 3
Started
2022-06-16
Last updated
2026-07-17

Condition(s) studied

Adult Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

mocravimod

mocravimod: S1PR modulator

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (111)

FacilityCityRegionStatus
University of Alabama Hospital (UAB Hospital) Birmingham Alabama Active Not Recruiting
Banner MD Anderson Cancer Center Gilbert Arizona Withdrawn
City of Hope Comprehensive Cancer Center - Duarte Duarte California Recruiting
University of California Los Angeles (UCLA) - David Geffen School of Medicine Los Angeles California Recruiting
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center Aurora Colorado Withdrawn
Moffitt Cancer Center Tampa Florida Recruiting
Emory University - Winship Cancer Institute (WCI) Atlanta Georgia Recruiting
University of Iowa Hospitals and Clinics Iowa City Iowa Recruiting
University of Kansas Cancer Center Westwood Kansas Recruiting
Ochsner Medical Center (OMC) - New Orleans New Orleans Louisiana Withdrawn
University of Maryland Medical Center (UMMC) Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Withdrawn
Henry Ford Cancer Institute Detroit Michigan Recruiting
Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT) Grand Rapids Michigan Active Not Recruiting
University of Rochester Medical Center (URMC) Rochester New York Recruiting
Stony Brook University (SBU) - Cancer Center Stony Brook New York Active Not Recruiting
University of Cincinnati Medical Center (University Hospital) Cincinnati Ohio Recruiting
The Ohio State University Comprehensive Cancer Center (OSUCCC) Cleveland Ohio Recruiting
Oregon Health & Science University (OHSU) - Knight Cancer Institute Portland Oregon Recruiting
University of Pennsylvania - Abramson Cancer Center Philadelphia Pennsylvania Suspended
Baylor Charles A. Sammons Cancer Center Dallas Texas Recruiting
Hospital El Cruce - Dr. Nestor Kirchner Buenos Aires Argentina Recruiting
Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC Buenos Aires Argentina Recruiting
Sanatorio Allende (SA) - Nueva Cordoba Córdoba Argentina Withdrawn
Hospital Italiano La Plata La Plata Argentina Recruiting
CEPON - Centro de Pesquisas Oncologicas Florianópolis Santa Catarina Withdrawn
Hospital Erasto Gaertner Curicica Brazil Recruiting
Hospital Alemao Oswaldo Cruz (HAOC) São Paulo Brazil Recruiting
Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP) São Paulo Brazil Recruiting
Hospital Israelita Albert Einstein São Paulo Brazil Active Not Recruiting
Unicamp São Paulo Brazil Recruiting
Hospital Amaral Carvalho São Paulo Brazil Recruiting
Centre Hospitalier Universitaire (CHU) Angers Angers France Recruiting
Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez - Lille France Active Not Recruiting
Centre Hospitalier Lyon-Sud Lyon France Recruiting
CHRU Nancy Hopitaux de Brabois Nancy France Recruiting
CHU de Nantes - Hôtel Dieu Nantes France Active Not Recruiting
Hospital Saint Antoine Paris France Recruiting
Hôpital Saint Louis Paris France Active Not Recruiting
Strasbourg (UIC d'onco-hématologie - Hôpital de Hautepierre) Strasbourg France Not Yet Recruiting

+ 71 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05429632 on ClinicalTrials.gov ↗ ← All trials in the UK