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

Adult Acute Myeloid Leukemia Clinical Trial

— MO-TRANS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429632
• Other study ID #: Priothera SAS
• Status: Recruiting
• Phase: Phase 3
• Start date: June 16, 2022
• Est. completion date: November 2025

Study information

• Verified date: June 2023
• Source: Priothera SAS
• Contact: Malika Souquieres, MSc
• Phone: +33367510040
• Email: malika.souquieres[@]priothera.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 249
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Acute Myeloid Leukemia

Intervention

Drug:
• mocravimod
S1PR modulator

Locations

Country	Name	City	State
Argentina	Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC	Buenos Aires
Brazil	Hospital Erasto Gaertner	Curicica
Brazil	Unicamp	Sao Paulo
Brazil	Hospital Alemao Oswaldo Cruz (HAOC)	São Paulo
Brazil	Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)	São Paulo
France	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	Hôpital Saint Louis	Paris
France	Hospital Saint Antoine	Paris
France	Centre de Lutte Contre le Cancer (CLCC) - Institut Gustave-Roussy	Villejuif
Germany	Universitätsklinikum Halle	Halle
Germany	Universitaetsklinikum Jena - Klinik fuer Innere Medizin II	Jena
Germany	University of Leipzig Medical Center	Leipzig
Germany	LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen	Munich
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	The Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	The Chaim Sheba Medical Center	Tel HaShomer
Italy	Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria	Alessandria
Italy	Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno	Ascoli Piceno
Italy	Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMO	Firenze
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera San Gerardo - Monza	Monza
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Azienda Ospedaliera Ospedali Riuniti Marche Nord	Pesaro
Italy	Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)	San Giovanni Rotondo	Foggia
Japan	Kyushu University Hospital,	Fukuoka-shi
Japan	Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital	Hiroshima-shi
Japan	Kobe City Medical Center General Hospital	Kobe-shi
Japan	Kyoto University Hospital	Koto-Ku
Japan	Ehime Prefectural Centeral Hospital, Ehime	Matsuyama-shi
Japan	Japanese Red Cross Nagoya Daiichi Hospital (First Hospital)	Nagoya-shi	Aichi-Ken
Japan	Osaka Metropolitan University Hospital	Osaka-shi	Osaka-Fu
Japan	Hokkaido University Hospital	Sapporo-shi
Japan	Jichi Medical University (JMU) Hospital	Shimotsuke-shi	Tochigi-Ken
Japan	Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital	Tokyo
Japan	Oita University (OU) Hospital	Yufu
Poland	Uniwersyteckie Centrum Kliniczne (UCK)	Gdansk
Poland	Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) - Slaskie Centrum Hematologii I Transplantacji Szpiku	Katowice	Silesia
Poland	Sp Zoz Szpital Uniwersytecki W Krakowie	Krakow	Aichi-Ken
Romania	Spitalul Clinic Coltea	Bucharest
Romania	Institutul Regional de Oncologie Iasi, - Haematology Department	Iasi
Spain	Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)	Barcelona
Spain	Institut Catala d'Oncologia (ICO)	Barcelona
Spain	Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location	Barcelona
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	Hospital Universitari i Politecnic La Fe	Valencia
Switzerland	Universitaetsspital Basel	Basel
Taiwan	Changhua Christian Hospital	Changhua City
Taiwan	National Cheng-Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital (NTUH)	Taipei
United Kingdom	Imperial College, London	London
United States	Emory University - Winship Cancer Institute (WCI)	Atlanta	Georgia
United States	University of Maryland Medical Center (UMMC)	Baltimore	Maryland
United States	University of Alabama Hospital (UAB Hospital)	Birmingham	Alabama
United States	University of Cincinnati Medical Center (University Hospital)	Cincinnati	Ohio
United States	The Ohio State University Comprehensive Cancer Center (OSUCCC)	Cleveland	Ohio
United States	Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)	Grand Rapids	Michigan
United States	University of California Los Angeles (UCLA) - David Geffen School of Medicine	Los Angeles	California
United States	Ochsner Medical Center (OMC) - New Orleans	New Orleans	Louisiana
United States	University of Pennsylvania - Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Oregon Health & Science University (OHSU) - Knight Cancer Institute	Portland	Oregon
United States	University of Rochester Medical Center (URMC)	Rochester	New York
United States	Stony Brook University (SBU) - Cancer Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Priothera SAS

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  France,  Germany,  Israel,  Italy,  Japan,  Poland,  Romania,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival (RFS)	To compare the efficacy of mocravimod to that of placebo	12 months
Secondary	Overall survival (OS)	To compare mocravimod's effect on overall survival (OS) to that of placebo	24 months