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Mocravimod for AML Patients Undergoing Stem Cell Transplant

This study is testing mocravimod, a drug that works by affecting a specific pathway (RAF), as an additional and ongoing treatment for adults with acute myeloid leukemia (AML) who are receiving an allogeneic hematopoietic cell transplant (stem cell transplant). You may be able to join if you are between 18 and 75 years old, have certain types of AML (excluding acute promyelocytic leukemia), and are planning to have a stem cell transplant. The main goal is to see if mocravimod can improve how long patients live without their cancer returning (relapse-free survival) after 12 months. The current recruitment status is unclear, but the study plans to enroll 366 participants.

Study design
This is a multi-center study where participants are randomly assigned to receive either mocravimod or a placebo (an inactive substance), and neither you nor your doctors will know which you are receiving (double-blinded). The study plans to enroll 366 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, relapse-free survival, is measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05429632

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

Recruiting
PHASE3Ages 18–75InterventionalTreatment
Priothera SAS
~366 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:mocravimod

At a glance

Recruiting sites
66 of 111 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relapse-free survival (RFS)
Measured over 12 months

Conditions

Adult Acute Myeloid Leukemia

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Acute Myeloid Leukemia

Where it's being run

111 sites across 44 states
France10
Spain10
United Kingdom10
Japan9
Italy7
Brazil6
Argentina4
Germany4

Study leadership

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

Who to contact

Malika Souquieres, MSc
[email protected]
+33 (0) 6 40 91 26 76
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Relapse-free survival (RFS)12 months

    To compare the efficacy of mocravimod to that of placebo