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Mocravimod treatment for AML patients undergoing transplant

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

Phase 3 Interventional Priothera SAS · NCT05429632

This study is testing if a new treatment called mocravimod can help adults with acute myeloid leukemia who are getting a stem cell transplant feel better and have better outcomes compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment366 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorPriothera SAS Industry-sponsored
Drugs / interventionsalemtuzumab
Locations108 sites (Birmingham, Alabama and 107 other locations)
Trial IDNCT05429632 on ClinicalTrials.gov

What this trial studies

This multi-center, randomized, double-blinded, placebo-controlled trial aims to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment for adult patients with acute myeloid leukemia (AML) who are undergoing allogeneic hematopoietic cell transplantation (HCT). The study will include patients diagnosed with high-risk or intermediate-risk AML and will assess the impact of mocravimod on treatment outcomes compared to a placebo. Participants will be monitored for safety and efficacy throughout the trial period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with high-risk or intermediate-risk AML who are planning to undergo allogeneic HCT.

Not a fit: Patients with certain pre-existing conditions or those receiving specific GvHD prophylaxis treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes and reduce relapse rates in AML patients undergoing transplantation.

How similar studies have performed: Other studies have shown promise with similar approaches in AML treatment, but the specific use of mocravimod in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 107 other locations

+58 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Adult Acute Myeloid Leukemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.