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 (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 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, 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

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 45 Locations for this study

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University of Alabama Hospital (UAB Hospital)
Birmingham Alabama, 35233, United States More Info
Antonio Di Stasi, MD
Contact
[email protected]
Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
University of California Los Angeles (UCLA) - David Geffen School of Medicine
Los Angeles California, 90095, United States
Emory University - Winship Cancer Institute (WCI)
Atlanta Georgia, 30322, United States More Info
Edmund Waller, MD
Contact
[email protected]
Ochsner Medical Center (OMC) - New Orleans
New Orleans Louisiana, 70121, United States
University of Maryland Medical Center (UMMC)
Baltimore Maryland, 21201, United States
Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)
Grand Rapids Michigan, 49503, United States More Info
Sami Brake, MD
Contact
[email protected]
University of Rochester Medical Center (URMC)
Rochester New York, 14642, United States More Info
Eric Huselton, MD
Contact
[email protected]
Stony Brook University (SBU) - Cancer Center
Stony Brook New York, 11794, United States More Info
Fengshuo Lan, MD
Contact
[email protected]
University of Cincinnati Medical Center (University Hospital)
Cincinnati Ohio, 45267, United States
The Ohio State University Comprehensive Cancer Center (OSUCCC)
Cleveland Ohio, 44106, United States More Info
Gabriella Pettito, MD
Contact
[email protected]
Oregon Health & Science University (OHSU) - Knight Cancer Institute
Portland Oregon, 97239, United States More Info
Arpita Gandhi, MD
Contact
[email protected]
University of Pennsylvania - Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States More Info
David Porter, MD
Contact
[email protected]
Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Unicamp
Sao Paulo , 13083, Brazil
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo , 01327, Brazil
Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)
São Paulo , 05403, Brazil More Info
Gian Carlo Fatobene, MD
Contact
[email protected]
Centre Hospitalier Universitaire (CHU) Angers
Angers , , France More Info
Sylvain Thepot, MD
Contact
[email protected]
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 More Info
Marie Robin, MD
Contact
[email protected]
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
University of Leipzig Medical Center
Leipzig , 04103, Germany More Info
Georg-Nikolaus Franke, MP
Contact
.+49 341 97-13132
[email protected]
LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen
Munich , 81377, 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 More Info
Ron Ram, MD
Contact
[email protected]
The Chaim Sheba Medical Center
Tel HaShomer , , Israel More Info
Avichai Shimoni, MD
Contact
[email protected]
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
San Giovanni Rotondo Foggia, 71013, Italy More Info
Angelo M Carella, 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 More Info
Piero Galieni, MD
Contact
[email protected]
Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMO
Firenze , , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano , , Italy More Info
Giorgia Saporiti, MD
Contact
[email protected]
Azienda Ospedaliera San Gerardo - Monza
Monza , 20900, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy More Info
Nicola Polverelli, MD
Contact
[email protected]
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro , 61122, Italy
Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)
Nagoya-shi Aichi-Ken, 466-8, Japan
Osaka Metropolitan University Hospital
Osaka-shi Osaka-Fu, 545-8, Japan
Jichi Medical University (JMU) Hospital
Shimotsuke-shi Tochigi-Ken, 329-0, Japan
Kyushu University Hospital,
Fukuoka-shi , 812-8, Japan
Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital
Hiroshima-shi , 730-8, Japan
Kobe City Medical Center General Hospital
Kobe-shi , 650-0, Japan More Info
Takayuki Ishikawa, MD
Contact
[email protected]
Ehime Prefectural Centeral Hospital, Ehime
Matsuyama-shi , 790-0, Japan
Hokkaido University Hospital
Sapporo-shi , 060-8, Japan
Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital
Tokyo , , Japan
Oita University (OU) Hospital
Yufu , 87559, Japan
Sp Zoz Szpital Uniwersytecki W Krakowie
Krakow Aichi-Ken, 30-68, Poland
Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) - Slaskie Centrum Hematologii I Transplantacji Szpiku
Katowice Silesia, Siles, Poland More Info
Agata Wieczorkiewicz-Kabut
Contact
[email protected]
Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk , 80-95, Poland More Info
Agnieszka Piekarska, MD
Contact
[email protected]
Spitalul Clinic Coltea
Bucharest , , Romania
Institutul Regional de Oncologie Iasi, - Haematology Department
Iasi , 70048, Romania More Info
Angela Dascalescu, MD
Contact
[email protected]
Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Barcelona , 08035, Spain
Institut Catala d'Oncologia (ICO)
Barcelona , 8908, Spain More Info
Annalisa Paviglianiti, MD
Contact
[email protected]
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location
Barcelona , 8916, Spain
Hospital Universitario Virgen de las Nieves
Granada , , Spain More Info
Pedro Gonalez-Sierra, MD
Contact
[email protected]
Hospital Universitario de Gran Canaria ""
Las Palmas De Gran Canaria , , Spain More Info
Melisa Karina Torres Ochando, MD
Contact
[email protected]
Hospital De La Princesa
Madrid , , Spain
Hospital Universitario 12 de Octubre
Madrid , , Spain More Info
Maria Calbacho Robles, MD
Contact
[email protected]
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 More Info
Jaime Sanz Caballer, MD
Contact
Universitaetsspital Basel
Basel , , Switzerland
Changhua Christian Hospital
Changhua City , 500, Taiwan
National Cheng-Kung University Hospital
Tainan , 70403, Taiwan
National Taiwan University Hospital (NTUH)
Taipei , 10002, Taiwan
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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