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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Adult Acute Myeloid Leukemia

In brief

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

Key facts

Study ID

NCT05429632

Run by

Priothera SAS

People needed

366

Starts

2022-06-16

Expected to finish

2029-11-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospital Amaral Carvalho — São Paulo, Brazil (enrolling)
• CHRU Nancy Hopitaux de Brabois — Nancy, France (enrolling)
• Hospital Erasto Gaertner — Curicica, Brazil (enrolling)
• Unicamp — São Paulo, Brazil (enrolling)
• Centre Hospitalier Universitaire (CHU) Angers — Angers, France (enrolling)
• Centre Hospitalier Lyon-Sud — Lyon, France (enrolling)
• University of California Los Angeles (UCLA) - David Geffen School of Medicine — Los Angeles, California, United States (enrolling)
• University of Kansas Cancer Center — Westwood, Kansas, United States (enrolling)
• Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP) — São Paulo, Brazil (enrolling)
• University of Maryland Medical Center (UMMC) — Baltimore, Maryland, United States (enrolling)
• City of Hope Comprehensive Cancer Center - Duarte — Duarte, California, United States (enrolling)
• Henry Ford Cancer Institute — Detroit, Michigan, United States (enrolling)
• Emory University - Winship Cancer Institute (WCI) — Atlanta, Georgia, United States (enrolling)
• University of Rochester Medical Center (URMC) — Rochester, New York, United States (enrolling)
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (enrolling)
• University of Cincinnati Medical Center (University Hospital) — Cincinnati, Ohio, United States (enrolling)
• The Ohio State University Comprehensive Cancer Center (OSUCCC) — Cleveland, Ohio, United States (enrolling)
• Oregon Health & Science University (OHSU) - Knight Cancer Institute — Portland, Oregon, United States (enrolling)
• Hospital Alemao Oswaldo Cruz (HAOC) — São Paulo, Brazil (enrolling)
• Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States (enrolling)
• Hospital El Cruce - Dr. Nestor Kirchner — Buenos Aires, Argentina (enrolling)
• Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC — Buenos Aires, Argentina (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Hospital Italiano La Plata — La Plata, Argentina (enrolling)
• Hospital Saint Antoine — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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