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
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
Principal Investigator
Contact
Location
- UCLA Westwood