Clinical Trials in Italy / NCT05429632
Recruiting
Phase 3
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
NCT05429632 · tracked via the Priya Life Science Italy tracker
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
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)
- Relapse-free survival (RFS) — 12 months
To compare the efficacy of mocravimod to that of placebo
Trial sites (111)
| Facility | City | Region | Status |
|---|---|---|---|
| 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| Banner MD Anderson Cancer Center | Gilbert | Arizona | Withdrawn |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| UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center | Aurora | Colorado | Withdrawn |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 Italy