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

Overview

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

Full Title of Study: “A Prospective Randomized, Double-blind, Placebo-controlled, Multi-center Phase IIb Study to Evaluate the Efficacy and Safety of Mocravimod as an Adjunctive and Maintenance Treatment in Adult Acute Myeloid Leukemia (AML) Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2025

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).

Interventions

  • Drug: mocravimod
    • S1PR modulator

Arms, Groups and Cohorts

  • Experimental: 3mg mocravimod arm
    • 3 mg of mocravimod orally once per day for 12 months
  • Experimental: 1mg mocravimod arm
    • 1 mg of mocravimod orally once per day for 12 months
  • Placebo Comparator: Placebo arm
    • placebo orally once per day for 12 months

Clinical Trial Outcome Measures

Primary Measures

  • Relapse-free survival (RFS)
    • Time Frame: 12 months
    • To compare the efficacy of mocravimod to that of placebo

Secondary Measures

  • Overall survival (OS)
    • Time Frame: 24 months
    • To compare mocravimod’s effect on overall survival (OS) to that of placebo

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Priothera SAS
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Malika Souquieres, MSc, +33367510040, malika.souquieres@priothera.com

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