Clinical trial NCT05429632: Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Adult Acute Myeloid Leukemia
Lead sponsor: Priothera SAS
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, multicenter, randomized, double-blind, placebo-controlled, and 3-arm parallel group study
Primary purpose: TREATMENT

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

Detailed 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).

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 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 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

Primary outcomes:
measure: Relapse-free survival (RFS)
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital (UAB Hospital)
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center - Duarte
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA) - David Geffen School of Medicine
state: California
city: Atlanta
country: United States
facility: Emory University - Winship Cancer Institute (WCI)
state: Georgia
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Medical Center (OMC) - New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center (UMMC)
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Cancer Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)
state: Michigan
city: Rochester
country: United States
facility: University of Rochester Medical Center (URMC)
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University (SBU) - Cancer Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center (University Hospital)
state: Ohio
city: Cleveland
country: United States
facility: The Ohio State University Comprehensive Cancer Center (OSUCCC)
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU) - Knight Cancer Institute
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania - Abramson Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Charles A. Sammons Cancer Center
state: Texas
city: Buenos Aires
country: Argentina
facility: Hospital El Cruce - Dr. Nestor Kirchner
city: Buenos Aires
country: Argentina
facility: Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC
city: Córdoba
country: Argentina
facility: Sanatorio Allende (SA) - Nueva Cordoba
city: La Plata
country: Argentina
facility: Hospital Italiano La Plata
city: Florianopolis
country: Brazil
facility: CEPON - Centro de Pesquisas Oncologicas
state: Santa Catarina
city: Curicica
country: Brazil
facility: Hospital Erasto Gaertner
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Sao Paulo
country: Brazil
facility: Unicamp
city: São Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz (HAOC)
city: São Paulo
country: Brazil
facility: Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)
city: São Paulo
country: Brazil
facility: Hospital Amaral Carvalho
city: Angers
country: France
facility: Centre Hospitalier Universitaire (CHU) Angers
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez -
city: Lyon
country: France
facility: Centre Hospitalier Lyon-Sud
city: Nantes
country: France
facility: CHU de Nantes - Hôtel Dieu
city: Paris
country: France
facility: Hospital Saint Antoine
city: Paris
country: France
facility: Hôpital Saint Louis
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse Oncopole
city: Villejuif
country: France
facility: Centre de Lutte Contre le Cancer (CLCC) - Institut Gustave-Roussy
city: Halle
country: Germany
facility: Universitätsklinikum Halle
city: Jena
country: Germany
facility: Universitaetsklinikum Jena - Klinik fuer Innere Medizin II
city: Leipzig
country: Germany
facility: University of Leipzig Medical Center
city: Munich
country: Germany
facility: LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel Aviv
country: Israel
facility: The Tel Aviv Sourasky Medical Center
city: Tel HaShomer
country: Israel
facility: The Chaim Sheba Medical Center
city: San Giovanni Rotondo
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
state: Foggia
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
city: Ascoli Piceno
country: Italy
facility: Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno
city: Brindisi
country: Italy
facility: Azienda Sanitaria Localedella provincia di Brindisi -
city: Firenze
country: Italy
facility: Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMO
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi Lecce
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo - Monza
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pesaro
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Nagoya-shi
country: Japan
facility: Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)
state: Aichi-Ken
city: Anjo-shi
country: Japan
facility: Anjo-kosei Hospital
state: Aichi
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Isikawa
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital
state: Osaka-Fu
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University (JMU) Hospital
state: Tochigi-Ken
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital,
city: Hiroshima-shi
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital
city: Koto-Ku
country: Japan
facility: Kyoto University Hospital
city: Matsuyama-shi
country: Japan
facility: Ehime Prefectural Centeral Hospital, Ehime
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Saitama
country: Japan
facility: Jichi Medical University Saitama Medical Center
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital
city: Yufu
country: Japan
facility: Oita University (OU) Hospital
city: Krakow
country: Poland
facility: Sp Zoz Szpital Uniwersytecki W Krakowie
state: Aichi-Ken
city: Katowice
country: Poland
facility: Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) - Slaskie Centrum Hematologii I Transplantacji Szpiku
state: Silesia
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne (UCK)
city: Krakow
country: Poland
facility: Apteka NSSU
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Bucharest
country: Romania
facility: Spitalul Clinic Coltea
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi, - Haematology Department
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologia (ICO)
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria ""
city: Madrid
country: Spain
facility: Hospital De La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario - Universidad de Salamanca
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital (NTUH)
city: Taipei
country: Taiwan
facility: National Taiwan University Cancer Center
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales, Cardiff
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: London
country: United Kingdom
facility: University College Hospital,
city: London
country: United Kingdom
facility: Imperial College, London
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary;Manchester University
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals Norhtern Center for Cancer Care
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: The Ohio State University Comprehensive Cancer Center
name: Marcos DeLima, MD
role: PRINCIPAL_INVESTIGATOR
References: