Clinical Trial Details
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Phase IIIInterventional
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
Protocol: STUDY00004628NCT: NCT05429632
Overview
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Eligibility
| Ages | 18 Years - 75 Years |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
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
