Status:
RECRUITING
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
Lead Sponsor:
Priothera SAS
Conditions:
Adult Acute Myeloid Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Detailed 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 hematopoi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT05429632
Start Date
June 16 2022
End Date
November 1 2029
Last Update
December 5 2025
Active Locations (105)
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1
University of Alabama Hospital (UAB Hospital)
Birmingham, Alabama, United States, 35233-1932
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234-2165
3
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, United States, 91010
4
University of California Los Angeles (UCLA) - David Geffen School of Medicine
Los Angeles, California, United States, 90095