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Back|NCT05429632Recruiting
Official Title

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

Phase
Phase 3
Sponsor
Priothera SAS
Enrollment
366
Timeline
Jun 2022 → Nov 2029
About This Study

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

Eligibility Criteria

Inclusion Criteria

  • 1Diagnosis 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
  • 2European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, \[CRi\] is also allowable
  • 3Planned 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
  • 4Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5
  • 5Planned use of TAC-based GvHD prophylaxis
  • 6age ≥ 18 years and ≤ 75 years
  • 7Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

  • 1Use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis
  • 2Diagnosis of macular edema during screening
  • 3Cardiac/pulmonary/hepatic/renal dysfunction
  • 4Hepatic 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
  • 5Renal dysfunction with estimated creatinine clearance \< 45 mL/min by the Cockcroft-Gault formula
  • 6Diabetes mellitus
  • 7History or presence of uveitis at screening
  • 8History or diagnosis of macular edema

Locations

105 sites participating in this study

Emory University - Winship Cancer Institute (WCI)

Atlanta, Georgia 30322-1013

Recruiting

Edmund Waller, MD

ewaller@emory.edu

University of Alabama Hospital (UAB Hospital)

Birmingham, Alabama 35233-1932

Recruiting

Antonio Di Stasi, MD

adistasi@uabmc.edu

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234-2165

Active, Not Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →