Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
ConditionAdult Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPriothera SAS
About this trial
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- mocravimod
Treatment groups
366 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov