RecruitingPhase 3NCT05429632
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
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
Sponsor
Priothera SAS
Enrollment
366 participants
Start Date
Jun 16, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria7
- 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 Criteria8
- 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
Interventions
DRUGmocravimod
S1PR modulator
Locations(108)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05429632
Related Trials
Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia
NCT070144491 location
Relation Between Venetoclax Plasma Concentration and Remission in Adults with Acute Myeloid Leukemia (PREDICLAX)
NCT060458191 location
A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML
NCT063299991 location