Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 3

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

NCT ID: NCT05429632Sponsor: Priothera SASLast updated: 2026-06-18

Summary

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

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 cell transplantation (HCT).

Arms & interventions

  • Drugmocravimod

    S1PR modulator

Outcome measures

Primary

  • Relapse-free survival (RFS)

    To compare the efficacy of mocravimod to that of placebo

    Time frame: 12 months

Secondary

  • Overall survival (OS)

    Time frame: 24 months

Eligibility criteria

Sex: AllAge: 18 Years to 75 YearsHealthy volunteers: No
Inclusion 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 Exclusion Criteria: * 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

Study locations (21)

University of Alabama Hospital (UAB Hospital)

Birmingham, Alabama, 35233-1932

Active Not Recruiting

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234-2165

Withdrawn

City of Hope Comprehensive Cancer Center - Duarte

Duarte, California, 91010

Recruiting
Vaibhav Agrawal, MD · Contact
vagrawal@coh.org

University of California Los Angeles (UCLA) - David Geffen School of Medicine

Los Angeles, California, 90095

Recruiting
Steven Tsai, MD · Contact
sctsai@mednet.ucla.edu

UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center

Aurora, Colorado, 80045

Withdrawn

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting
Asmita Mishra, MD · Contact
asmita.mishra@moffitt.org

Emory University - Winship Cancer Institute (WCI)

Atlanta, Georgia, 30322-1013

Recruiting
Edmund Waller, MD · Contact
ewaller@emory.edu

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

Recruiting
Kittika Poonsombudlert, MD · Contact
kittika-poonsombudlert@uiowa.edu

University of Kansas Cancer Center

Westwood, Kansas, 66103

Recruiting
Haitham Abdelhakim, MD · Contact
habdelhakim@kumc.edu

Ochsner Medical Center (OMC) - New Orleans

New Orleans, Louisiana, 70121

Withdrawn

University of Maryland Medical Center (UMMC)

Baltimore, Maryland, 21201-1544

Recruiting
Jean Yared, MD · Contact
jyared@umm.edu

Massachusetts General Hospital

Boston, Massachusetts, 02114

Withdrawn

Henry Ford Cancer Institute

Detroit, Michigan, 48202-2610

Recruiting
Shatha Farhan, MD · Contact
sfarhan1@hfhs.org

Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)

Grand Rapids, Michigan, 49503

Active Not Recruiting

University of Rochester Medical Center (URMC)

Rochester, New York, 14642

Recruiting
Eric Huselton, MD · Contact
Eric_Huselton@URMC.Rochester.edu

Stony Brook University (SBU) - Cancer Center

Stony Brook, New York, 11794-0001

Active Not Recruiting

University of Cincinnati Medical Center (University Hospital)

Cincinnati, Ohio, 45267

Recruiting
Edward Faber, MD · Contact
513-584-4268fabered@ucmail.uc.edu

The Ohio State University Comprehensive Cancer Center (OSUCCC)

Cleveland, Ohio, 44106-1716

Recruiting
Sarah Wall, MD · Contact
sarah.wall@uhhospitals.org

Oregon Health & Science University (OHSU) - Knight Cancer Institute

Portland, Oregon, 97239-3098

Recruiting
Arpita Gandhi, MD · Contact
gandhiar@ohsu.edu

University of Pennsylvania - Abramson Cancer Center

Philadelphia, Pennsylvania, 19104-4206

Suspended

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246

Recruiting
Jane Reynolds, MD · Contact
Jana.Reynolds@BSWHealth.org
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT | Cancerify