A Phase IIb Placebo-controlled Efficacy and Safety Study of Mocravimod as an Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HSCT

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Priothera SAS

Criteria

Inclusion Criteria:

• Diagnosis of AML (excluding acute promyelocytic leukemia): European Leukemia Net (ELN) high risk AML in CR1, intermediate risk AML in CR1 if MRDpos, or AML of any risk in CR2.

• Planned allogeneic HSCT from fully matched sibling donor or unrelated donor using PBSC graft

• Planned use of protocol-suggested myeloablative conditioning regimen

• Planned use of CsA/MTX or TAC/MTX for 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), post-transplantation cyclophosphamide (PTCY), sirolimus, MMF, abatacept, or any other approved or non-approved medication other than MTX plus CsA or MTX plus TAC

• Diagnosis of macular edema during screening

• Cardiac/pulmonary/hepatic/renal dysfunction (conduction blockers, or quinidine)

• 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