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Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

NCT05429632

RecruitingPhase 3

Sponsor: Priothera SAS

Conditions: Adult Acute Myeloid Leukemia

Interventions: mocravimod

Countries: United States, Argentina, Brazil, France, Germany, Israel, Italy, Japan

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

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 TAC-based GvHD prophylaxis
* age ≥ 18 years and ≤ 75 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* 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
Locations (111)
  • Birmingham, Alabama, United States
  • Gilbert, Arizona, United States
  • Duarte, California, United States
  • Los Angeles, California, United States
  • Aurora, Colorado, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Iowa City, Iowa, United States
  • Westwood, Kansas, United States
  • New Orleans, Louisiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Rochester, New York, United States
  • Stony Brook, New York, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Dallas, Texas, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Córdoba, Argentina
  • La Plata, Argentina
  • Florianópolis, Santa Catarina, Brazil
  • Curicica, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • + 81 more on CT.gov