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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 II

Eligibility

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

Inclusion Criteria:

  • Diagnosis of AML according to the WHO 2022 classification (excluding acute promyelocytic leukemia) and European Leukemia Net (ELN) high risk AML in CR1, intermediate risk AML in CR1, or AML of any risk in CR2.
  • Planned allogeneic HCT from fully matched sibling donor or unrelated donor with no more than 1 antigen mismatch using PBSC graft
  • Planned use of myeloablative conditioning regimen that is expected to result in donor chimerism of > 90%
  • 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, sirolimus, 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 < 60 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.