Mocravimod treatment for AML patients undergoing transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• City of Hope Comprehensive Cancer Center - Duarte
  Duarte, California, United States Recruiting
• University of California Los Angeles (UCLA) - David Geffen School of Medicine
  Los Angeles, California, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Emory University - Winship Cancer Institute (WCI)
  Atlanta, Georgia, United States Recruiting
• University of Iowa Hospitals and Clinics
  Iowa City, Iowa, United States Recruiting
• University of Kansas Cancer Center
  Westwood, Kansas, United States Recruiting

+61 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Marcos DeLima, MD — The Ohio State University Comprehensive Cancer Center
• Study coordinator: Malika Souquieres, MSc
• Email: malika.souquieres@priothera.com
• Phone: +33 (0) 6 40 91 26 76

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.