Acute Myeloid Leukemia Clinical Trial

Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

Summary

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

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Full 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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of AML according to the WHO 2022 classification (excluding acute promyelocytic leukemia) and European Leukemia Net (ELN) high risk AML in CR1, intermediate risk AML in CR1, or AML of any risk in CR2.
Planned allogeneic HCT from fully matched sibling donor or unrelated donor with no more than 1 antigen mismatch using PBSC graft
Planned use of myeloablative conditioning regimen that is expected to result in donor chimerism of > 90%
Planned use of CsA-based or 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 anti-thymocyte globulin (ATG), alemtuzumab, sirolimus, 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 < 60 mL/min by the Cockcroft-Gault formula

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

249

Study ID:

NCT05429632

Recruitment Status:

Recruiting

Sponsor:

Priothera SAS

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There are 11 Locations for this study

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University of Alabama Hospital (UAB Hospital)
Birmingham Alabama, 35233, United States
University of California Los Angeles (UCLA) - David Geffen School of Medicine
Los Angeles California, 90095, United States
University of Maryland Medical Center (UMMC)
Baltimore Maryland, 21201, United States
Stony Brook University (SBU) - Cancer Center
Stony Brook New York, 11794, United States
The Ohio State University Comprehensive Cancer Center (OSUCCC)
Cleveland Ohio, 44106, United States
Centre Hospitalier Universitaire (CHU) Angers
Angers , , France
Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez -
Lille , , France
CHU de Nantes - Hôtel Dieu
Nantes , , France More Info
Patrice Chevallier, MD
Contact
[email protected]
Hospital Saint Antoine
Paris , , France More Info
Florent Mallard, MD
Contact
[email protected]
Hôpital Saint Louis
Paris , , France
Centre de Lutte Contre le Cancer (CLCC) - Institut Gustave-Roussy
Villejuif , , France
Universitätsklinikum Halle
Halle , , Germany
Universitaetsklinikum Jena - Klinik fuer Innere Medizin II
Jena , 07747, Germany
Rambam Health Care Campus
Haifa , , Israel More Info
Tsila Zuckermann, MD
Contact
[email protected]
Hadassah Medical Center
Jerusalem , , Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv , , Israel
The Chaim Sheba Medical Center
Tel HaShomer , , Israel More Info
Avichai Shimoni, MD
Contact
[email protected]
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
Alessandria , 15121, Italy
Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno
Ascoli Piceno , 63100, Italy
Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMO
Firenze , , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano , , Italy
Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Barcelona , 08035, Spain
Institut Catala d'Oncologia (ICO)
Barcelona , 8908, Spain
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location
Barcelona , 8916, Spain
Hospital Universitario Virgen de las Nieves
Granada , , Spain
Hospital Universitario de Gran Canaria ""
Las Palmas De Gran Canaria , , Spain
Hospital De La Princesa
Madrid , , Spain
Hospital Universitario 12 de Octubre
Madrid , , Spain
Hospital Universitario Ramon y Cajal
Madrid , , Spain
Hospital Clinico Universitario - Universidad de Salamanca
Salamanca , , Spain More Info
Estefanía Pérez López, MD
Contact
[email protected]
Hospital Universitari i Politecnic La Fe
Valencia , , Spain
Universitaetsspital Basel
Basel , , Switzerland
Imperial College, London
London , , United Kingdom More Info
Eduardo Olavarria, MD
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

249

Study ID:

NCT05429632

Recruitment Status:

Recruiting

Sponsor:


Priothera SAS

How clear is this clinincal trial information?

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