Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
Purpose
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Condition
- Adult Acute Myeloid Leukemia
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 CsA-based or 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 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- prospective, multicenter, randomized, double-blind, placebo-controlled, and 3-arm parallel group study
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
University of Alabama Hospital (UAB Hospital)
Birmingham, Alabama 35233-1932
Birmingham, Alabama 35233-1932
More Details
- Status
- Recruiting
- Sponsor
- Priothera SAS
Detailed Description
The purpose of this study is to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (HCT).