Adult Acute Myeloid Leukemia
Conditions
Brief summary
This is a multi-center, randomized, double-blinded, placebo controlled trial.
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).
Interventions
DRUGmocravimod
S1PR modulator
Sponsors
Priothera SAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
prospective, multicenter, randomized, double-blind, placebo-controlled, and 3-arm parallel group study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-free survival (RFS) | 12 months | To compare the efficacy of mocravimod to that of placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 24 months | To compare mocravimod's effect on overall survival (OS) to that of placebo |
Countries
Argentina, Brazil, France, Germany, Israel, Italy, Japan, Poland, Romania, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
CONTACTMalika Souquieres, MSc
CONTACTJens Hasskarl, MD
PRINCIPAL_INVESTIGATORMarcos DeLima, MD
The Ohio State University Comprehensive Cancer Center
Outcome results
None listed