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 Sex
- 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 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
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 4049979, Alabama 4829764 35233-1932
Birmingham 4049979, Alabama 4829764 35233-1932
Emory University - Winship Cancer Institute (WCI)
Atlanta 4180439, Georgia 4197000 30322-1013
Atlanta 4180439, Georgia 4197000 30322-1013
Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
University of Rochester Medical Center (URMC)
Rochester 5134086, New York 5128638 14642
Rochester 5134086, New York 5128638 14642
Stony Brook University (SBU) - Cancer Center
Stony Brook 5139865, New York 5128638 11794-0001
Stony Brook 5139865, New York 5128638 11794-0001
The Ohio State University Comprehensive Cancer Center (OSUCCC)
Cleveland 5150529, Ohio 5165418 44106-1716
Cleveland 5150529, Ohio 5165418 44106-1716
Oregon Health & Science University (OHSU) - Knight Cancer Institute
Portland 5746545, Oregon 5744337 97239-3098
Portland 5746545, Oregon 5744337 97239-3098
University of Pennsylvania - Abramson Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19104-4206
Philadelphia 4560349, Pennsylvania 6254927 19104-4206
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).