Open Actively Recruiting

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

About

Brief Summary

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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
75 Years

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 CsA-based or 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 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

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Study Stats
Protocol No.
22-001054
Category
Leukemia
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05429632
For detailed technical eligibility, visit ClinicalTrials.gov.