A phase IIb placebo-controlled efficacy and safety study of mocravimod as an adjunctive and maintenance treatment in AML patients undergoing allo-HSCT (MO-TRANS Study)
- Conditions
- Adjunctive and maintenance treatment to HSCTMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2021-002864-36-ES
- Lead Sponsor
- Priothera S.A.S.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 249
1.Subjects with a diagnosis of AML (excluding acute promyelocytic leukemia) according to the World Health Organization (WHO) 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 European LeukemiaNet (ELN) high risk AML in CR1, intermediate risk AML in CR1 if MRDpos, or AML of any risk in CR2.
- Complete remission is defined as: < 5% marrow blasts by morphologic examination and no circulating peripheral blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count = 1.0x109/L (1000/µL); platelet count = 100x109/L (100 000/µL)
3.Subjects planned to undergo allogeneic HSCT
4.Life expectancy = 6 months at screening.
5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6.Male or female, age = 18 years and = 75 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 49
1.Planned use of anti-thymocyte globulin (ATG), post-transplantation cyclophosphamide, sirolimus, mycophenolate mofetil, abatacept, or any approved or non-approved medication other than MTX plus CsA or MTX plus TAC for GVHD prophylaxis.
2.Planned use of serotherapy during conditioning, including ATG and alemtuzumab.
3.Planned ex vivo major graft manipulation, including T-cell depletion or CD34+ selection.
4.Subjects having received prior allogeneic HSCT or recipients of a solid organ transplant.
5.Immunosuppressive drugs for concomitant disease. Subjects must be able to be off prednisone (> 10 mg/day) or other immunosuppressive medications for at least 3 days prior to the start of treatment of the study. Physiologic replacement dosing of hydrocortisone is permissible.
6.Require treatments for cardiac dysfunction
7.Subjects with acute promyelocytic leukemia.
8.Blast crisis of chronic myeloid leukemia
9.Cardiac dysfunction
10.Pulmonary dysfunction.
11.Significant liver disease or liver injury or known history of alcohol abuse, chronic liver or biliary disease. 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 x ULN
12.Renal dysfunction with creatinine clearance < 60 mL/min by the Cockcroft-Gault formula.
13.History of stroke or intracranial hemorrhage within 1 year prior to screening.
14.Active clinically significant infection (viral, bacterial, or fungal) that requires ongoing antimicrobial therapy and in the judgment of the investigator represents a risk to proceeding with HSCT.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of mocravimod to that of placebo;Secondary Objective: To compare mocravimod's effect on overall survival (OS) to that of placebo;Primary end point(s): Relapse-free survival (RFS);Timepoint(s) of evaluation of this end point: following 46 events occurred (relapse or death of any cause)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Overall survival (OS)<br>-Time to relapse<br>-Non-relapse mortality;Timepoint(s) of evaluation of this end point: Event-driven trial