Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HCT

ReclutandoFase 3ClinicalTrials.gov

ID: NCT05429632Tipo: INTERVENTIONALInicio: 16 de jun de 2022Fin estimado: 1 de nov de 2029

Oncología

Traducción no disponible, mostrando original

Resumen

This is a multi-center, randomized, double-blinded, placebo controlled trial.

Descripción detallada

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).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

mocravimod

S1PR modulator

Ubicaciones

Hospital El Cruce - Dr. Nestor Kirchner

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Sanatorio Allende (SA) - Nueva Cordoba

Córdoba, Argentina

ACTIVE_NOT_RECRUITING

Hospital Italiano La Plata

La Plata, Argentina

ACTIVE_NOT_RECRUITING

Patrocinadores

PrincipalPriothera SAS

Contactos

Malika Souquieres, MSc

CONTACT

malika.souquieres@priothera.com +33 (0) 6 40 91 26 76

Jens Hasskarl, MD

CONTACT

jens.hasskarl@priothera.com +41 79 5432099

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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