Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

Description

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

Conditions

Adult Acute Myeloid Leukemia

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Study Overview

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Study Details

Study overview

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

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

Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

Condition
Adult Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Hospital (UAB Hospital), Birmingham, Alabama, United States, 35233-1932

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234-2165

Duarte

City of Hope Comprehensive Cancer Center - Duarte, Duarte, California, United States, 91010

Los Angeles

University of California Los Angeles (UCLA) - David Geffen School of Medicine, Los Angeles, California, United States, 90095

Atlanta

Emory University - Winship Cancer Institute (WCI), Atlanta, Georgia, United States, 30322-1013

Westwood

University of Kansas Cancer Center, Westwood, Kansas, United States, 66103

New Orleans

Ochsner Medical Center (OMC) - New Orleans, New Orleans, Louisiana, United States, 70121

Baltimore

University of Maryland Medical Center (UMMC), Baltimore, Maryland, United States, 21201-1544

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Detroit

Henry Ford Cancer Institute, Detroit, Michigan, United States, 48202-2610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 TAC-based GvHD prophylaxis
  • * age ≥ 18 years and ≤ 75 years
  • * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • * Use of CsA, 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
  • * Diabetes mellitus
  • * History or presence of uveitis at screening
  • * History or diagnosis of macular edema

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Priothera SAS,

Marcos DeLima, MD, PRINCIPAL_INVESTIGATOR, The Ohio State University Comprehensive Cancer Center

Study Record Dates

2029-11