Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Details

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 cell transplantation (HCT).

Keywords

Adult Acute Myeloid Leukemia, mocravimod

Eligibility

You can join if…

Open to people ages 18-75

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Los Angeles (UCLA) - David Geffen School of Medicine in progress, not accepting new patients
    Los Angeles California 90095 United States
  • Oregon Health & Science University (OHSU) - Knight Cancer Institute in progress, not accepting new patients
    Portland Oregon 97239-3098 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Priothera SAS
Links
Sign up for this study
ID
NCT05429632
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 249 study participants
Last Updated