Patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) for acute myeloid leukemia (AML) MedDRA version: 20.1 Level: PT Classification code 10018651 Term: Graft versus host disease System Organ Class: 10021428 - Immune system disorders
Conditions
Sponsors
Priothera S.A.S.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with a diagnosis of AML (excluding acute promyelocytic leukemia) according to the World Health Organization 2016 classification of AML and related precursor neoplasms, including secondary AML after an antecedent hematological disease (e.g. myelodysplastic syndrome) and therapy-related AML. 2. Subjects with ELN high risk AML in CR1 or any other AML in CR2. (Complete remission with incomplete count recovery [CRi] is also allowable). o Complete remission is defined as leukemia clearance (=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1.Planned use of tacrolimus, anti-thymocyte globulin (ATG), post-transplantation cyclophosphamide, or mycophenolate mofetil for GVHD prophylaxis. 2.Planned use of serotherapy during conditioning 3.Planned ex vivo major graft manipulation 4.Subjects having received prior allogeneic HSCT or recipients of a solid organ transplant 5.Vaccination within 4 weeks prior to screening 6.Immunosuppressive drugs for concomitant disease. Subjects off prednisone or other immunosuppressive medications 450 msec for males and >470 msec for females at Screening or Baseline ECG -History or presence of symptomatic arrhythmia or arrhythmia requiring treatment or of clinical significance -Uncontrolled arterial hypertension; if controlled, the medication must be stable for 3 months prior to baseline -Requiring treatment with prohibited medication -History of syncope of suspected cardiac origin -History of familial long QT syndrome or known family history of Torsades de Pointes 14.Pulmonary dysfunction as defined by oxygen saturation <90% on room air. PFT is required only in the case of symptomatic or prior known impairments within 6weeks before signing ICF -with pulmonary function <50% corrected diffusing capacity of the lung for carbon monoxide (DLCO) and <50% predicted forced expiratory volume in 1 second (FEV1). 15.Significant liver diseas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess mocravimod’s effect as an adjunctive therapy to HSCT on GVHD and GVL after a 12-month treatment period.;Secondary Objective: To assess mocravimod’s effect on overall survival (OS) at 24 months, following a 12-month treatment and a 12-month follow-up period.;Primary end point(s): Refractory GVHD-free, relapse-free survival (rGRFS) at Month 12 after HSCT;Timepoint(s) of evaluation of this end point: Month 12 after HSCT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival (OS) at Month 24 after HSCT; - Relapse-free survival (RFS) at Month 24 after HSCT; - Survival free from refractory acute GVHD (aGVHD) at Month 12 after HSCT; - Survival free from moderate/severe chronic GVHD (cGVHD) at Month 12 and at Month 24 after HSCT; - Non-relapse related mortality at Month 12 and at Month 24 after HSCT; - Cumulative incidence of relapse at Month 12 and at Month 24 after HSCT; - rGRFS at Month 24 after HSCT; ;Timepoint(s) of evaluation of this end point: - Month 24 after HSCT; - Month 12 and at Month 24 after HSCT. | — |
Countries
Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Sciences & Operations
Priothera S.A.S.
Outcome results
None listed