Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCLA
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 IIb Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HSCT

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 stem cell transplantation (HSCT).

Keywords

Adult Acute Myeloid Leukemia, mocravimod

Eligibility

You can join if…

Open to people ages 18-75

  • 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

You CAN'T join if...

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

Locations

  • University of California Los Angeles (UCLA) - David Geffen School of Medicine in progress, not accepting new patients
    Los Angeles California 90095 United States
  • Imperial College, London accepting new patients
    London United Kingdom

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 2 research study
Study Type
Interventional
Participants
Expecting 249 study participants
Last Updated