Recruiting
Phase 3

Mocravimod

Sponsor:

Priothera SAS

Code:

NCT05429632

Conditions

Adult Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

mocravimod

Study Details

Brief summary:

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

Conditions

Adult Acute Myeloid Leukemia

Study ID

NCT05429632

Start date

Jun 16, 2022

Status verified date

Jul, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

366 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 3mg mocravimod arm

3 mg of mocravimod orally once per day for 12 months

experimental: 1mg mocravimod arm

1 mg of mocravimod orally once per day for 12 months

placebo comparator: Placebo arm

placebo orally once per day for 12 months

Interventions

mocravimod

S1PR modulator

Primary outcome measure

  • Relapse-free survival (RFS) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Malika Souquieres, MSc

+33 (0) 6 40 91 26 76malika.souquieres@priothera.com

Jens Hasskarl, MD

+41 79 5432099jens.hasskarl@priothera.com

Locations

City of Hope Comprehensive Cancer Center - Duarte

Recruiting

Duarte, California, United States, 91010

Contacts

Vaibhav Agrawal, MD

vagrawal@coh.org

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

Recruiting

Los Angeles, California, United States, 90095

Contacts

Steven Tsai, MD

sctsai@mednet.ucla.edu

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Asmita Mishra, MD

asmita.mishra@moffitt.org

Emory University - Winship Cancer Institute (WCI)

Recruiting

Atlanta, Georgia, United States, 30322-1013

Contacts

Edmund Waller, MD

ewaller@emory.edu

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Kittika Poonsombudlert, MD

kittika-poonsombudlert@uiowa.edu

University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66103

Contacts

Haitham Abdelhakim, MD

habdelhakim@kumc.edu

University of Maryland Medical Center (UMMC)

Recruiting

Baltimore, Maryland, United States, 21201-1544

Contacts

Jean Yared, MD

jyared@umm.edu

Henry Ford Cancer Institute

Recruiting

Detroit, Michigan, United States, 48202-2610

Contacts

Shatha Farhan, MD

sfarhan1@hfhs.org

University of Rochester Medical Center (URMC)

Recruiting

Rochester, New York, United States, 14642

Contacts

Eric Huselton, MD

Eric_Huselton@URMC.Rochester.edu

University of Cincinnati Medical Center (University Hospital)

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Edward Faber, MD

513-584-4268fabered@ucmail.uc.edu

The Ohio State University Comprehensive Cancer Center (OSUCCC)

Recruiting

Cleveland, Ohio, United States, 44106-1716

Contacts

Sarah Wall, MD

sarah.wall@uhhospitals.org

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

Recruiting

Portland, Oregon, United States, 97239-3098

Contacts

Arpita Gandhi, MD

gandhiar@ohsu.edu

Baylor Charles A. Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Jane Reynolds, MD

Jana.Reynolds@BSWHealth.org

More Information

Sponsor

Priothera SAS

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Priothera SAS on 2026-07-17.