Study on Mocravimod as Additional and Ongoing Treatment for AML Patients Undergoing Stem Cell Transplant
Sponsor: Priothera SAS
ClinicalTrials ID:NCT05429632
This clinical trial is testing the safety and effectiveness of a drug called mocravimod as an additional treatment for adults with acute myeloid leukemia (AML) who are receiving a stem cell transplant from a donor.
Patient Parameters
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Program Overview
The study aims to find out if mocravimod can help improve outcomes for adults with acute myeloid leukemia (AML) who are undergoing a stem cell transplant from a donor. The trial will compare mocravimod to a placebo to see if it is safe and effective as an additional and ongoing treatment.
Description
This study is designed to evaluate how well mocravimod works and how safe it is when used as an extra treatment for adults with acute myeloid leukemia (AML) who are receiving a stem cell transplant from a donor. The trial is conducted at multiple centers and involves randomly assigning participants to receive either mocravimod or a placebo, without knowing which one they are getting. The goal is to see if mocravimod can help improve the success of the transplant and maintain remission in these patients.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with acute myeloid leukemia (AML), excluding a specific type called acute promyelocytic leukemia.
- Classified as high-risk or intermediate-risk AML in first complete remission (CR1), or any risk level in second complete remission (CR2).
- Planning to receive a stem cell transplant from a fully matched donor or a partially matched donor using specific criteria.
- Any conditioning treatment with a score of 1.5 or higher.
- Planning to use a specific type of medication to prevent graft-versus-host disease (GvHD).
- Aged between 18 and 75 years old.
- In good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Use of certain medications for preventing graft-versus-host disease (GvHD).
- Diagnosis of a specific eye condition called macular edema during screening.
- Heart, lung, liver, or kidney problems.
- Liver issues with specific enzyme levels more than 2.5 times the normal limit or total bilirubin over 1.5 mg/dL.
- Kidney issues with creatinine clearance less than 45 mL/min.
- Diabetes.
- History or presence of eye inflammation (uveitis) at screening.
- History or diagnosis of macular edema.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama Hospital (UAB Hospital) | 35233-1932 | Birmingham | Alabama |
| Banner MD Anderson Cancer Center | 85234-2165 | Gilbert | Arizona |
| City of Hope Comprehensive Cancer Center - Duarte | 91010 | Duarte | California |
| University of California Los Angeles (UCLA) - David Geffen School of Medicine | 90095 | Los Angeles | California |
| Emory University - Winship Cancer Institute (WCI) | 30322-1013 | Atlanta | Georgia |
| University of Kansas Cancer Center | 66103 | Westwood | Kansas |
| Ochsner Medical Center (OMC) - New Orleans | 70121 | New Orleans | Louisiana |
| University of Maryland Medical Center (UMMC) | 21201-1544 | Baltimore | Maryland |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Henry Ford Cancer Institute | 48202-2610 | Detroit | Michigan |
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