Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HCT
Priothera SAS
Summary
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Description
The purpose of this study is to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (HCT).
Eligibility
- Age range
- 18–75 years
- Sex
- All
- 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…
Interventions
- Drugmocravimod
S1PR modulator
Locations (108)
- University of Alabama Hospital (UAB Hospital)Birmingham, Alabama
- Banner MD Anderson Cancer CenterGilbert, Arizona
- City of Hope Comprehensive Cancer Center - DuarteDuarte, California
- University of California Los Angeles (UCLA) - David Geffen School of MedicineLos Angeles, California
- UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer CenterAurora, Colorado
- Moffitt Cancer CenterTampa, Florida