Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCLA
Dates
study started
completion around

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 (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 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, 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

Locations

  • University of California Los Angeles (UCLA) - David Geffen School of Medicine in progress, not accepting new patients
    Los Angeles California 90095 United States
  • Banner MD Anderson Cancer Center in progress, not accepting new patients
    Gilbert Arizona 85234-2165 United States
  • University of Alabama Hospital (UAB Hospital) accepting new patients
    Birmingham Alabama 35233-1932 United States
  • Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT) accepting new patients
    Grand Rapids Michigan 49503 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
ID
NCT05429632
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 249 study participants
Last Updated