Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT (MO-TRANS)
Status
Recruiting
NCT05429632
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 Overview
Allogeneic HCT is a standard treatment of curative intent for AML. A major limitation for successful outcome of allogeneic HCT is disease relapse. The Graft-versus-leukemia (GvL) effect is also critical to prevent disease relapse and is mediated by donor T cells contained in the HCT graft that trigger immune responses against leukemic cells.
Mocravimod is an oral S1P receptor (S1PR) modulator that blocks lymphocyte egress from lymphoid organs via its phosphorylated active metabolite. Mocravimod’s potential to preserve the desirable GvL effect while decreasing GvHD is a promising way to maintain the prospect of a cure while decreasing transplant-related mortality (TRM) and morbidity in AML patients undergoing allogeneic HCT.
Study Design
This is a multi-center, randomized, double-blinded, placebo-controlled trial.
Purpose
The purpose of this pivotal study is to assess the efficacy and safety of mocravimod compared with placebo as an adjunctive and maintenance treatment for allogeneic hematopoietic cell transplantation (HCT) in combination with a standard of care GvHD prophylaxis in adult high-risk AML patients in first complete remission (CR1), intermediate-risk AML patients in CR1 or any AML patients in second complete remission (CR2).
Interested in Participating?
Participation
Requirements
18-75
Sex
Males and Females
Healthy Volunteers
No
Adult Acute Myeloid Leukemia undergoing 1st allogeneic HCT
Conditions
High or intermediate risk AML in CR1, any risk AML in CR2
Study Details
Recruiting
Locations
Worldwide
Study Type
Interventional
Phase 3
Product
Oral Mocravimod
Sponsor
Priothera SAS
Eligibility
Inclusion
- 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
- 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 locations
The current locations for studies in the US are listed below, and additional locations may be included as they become available. If you do not find a study location in your area, please visit ClinicalTrials.gov to check if a local study site has been added.
| Study Contact Malika Souquieres, MSc +33 3 67 51 00 40 malika.souquieres@priothera.com |
| Study Contact Backup Elisabeth Kueenburg, MD +33 3 67 51 00 40 elisabeth.kueenburg@priothera.com |
United States
Alabama Locations
University of Alabama Hospital (UAB Hospital)
adistasi@uabmc.edu
Arizona Locations
Banner MD Anderson Cancer Center
California Locations
University of California Los Angeles (UCLA) – David Geffen School of Medicine
Georgia Locations
Emory University – Winship Cancer Institute (WCI)
ewaller@emory.edu
Louisiana Locations
Ochsner Medical Center (OMC) – New Orleans
Maryland Locations
University of Maryland Medical Center (UMMC)
Michigan Locations
Spectrum Health Medical Group (SHMG) – Blood & Marrow Transplant – Adult (BMT)
Sami.Brake@spectrumhealth.org
New York Locations
Stony Brook University (SBU) – Cancer Center
Fengshuo.Lan@stonybrookmedicine.edu
Ohio Locations
University of Cincinnati Medical Center (University Hospital)
The Ohio State University Comprehensive Cancer Center (OSUCCC)
Gabriella.Pettito@uhhospitals.org
Oregon Locations
Oregon Health & Science University (OHSU) – Knight Cancer Institute
gandhiar@ohsu.edu
Pennsylvania Locations
University of Pennsylvania – Abramson Cancer Center
Texas Locations
Baylor Charles A. Sammons Cancer Center
Israel
Rambam Health Care Campus
Contact:
Tsila Zuckermann, MD
t_zuckerman@rambam.health.gov
Jerusalem, Israel
Hadassah Medical Center
Tel Aviv, Israel
The Tel Aviv Sourasky Medical Center
Contact:
Ron Ram, MD
ronr@tlvmc.gov.il
Tel HaShomer, Israel
The Chaim Sheba Medical Center
Contact:
Avichai Shimoni, MD
avichai.Shimoni@sheba.health.gov.il
Romania
Spitalul Clinic Coltea
Iasi, Romania, 700483
Institutul Regional de Oncologie Iasi, – Haematology Department
Contact:
Angela Dascalescu, MD
angdascalescu@yahoo.com
United Kingdom
Imperial College, London
Contact:
Eduardo Olavarria, MD
e.olavarria@nhs.net
Brazil
São Paulo, Brazil, 01327-001
Hospital Alemao Oswaldo Cruz (HAOC)
Germany
Universitätsklinikum Halle
Jena, Germany, 07747
Universitaetsklinikum Jena – Klinik fuer Innere Medizin II
Leipzig, Germany, 04103
University of Leipzig Medical Center
Contact:
Georg-Nikolaus Franke, MP
+49 341 97-13132
Georg-Nikolaus.Franke@medizin.uni-leipzig.de
Munich, Germany, 81377
LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen
Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
Ascoli Piceno, Italy, 63100
Azienda Sanitaria Locale 13 – Ospedale “C. e G. Mazzoni”- Ascoli Piceno
Contact:
Piero Galieni, MD
piero.galieni@sanita.marche.it
Firenze, Italy
Universita degli Studi di Firenze – Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB TMO
Milano, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Contact:
Giorgia Saporiti, MD
giorgia.saporiti@policlinico.mi.it
Monza, Italy, 20900
Azienda Ospedaliera San Gerardo – Monza
Pavia, Italy, 27100
Fondazione IRCCS Policlinico San Matteo
San Giovanni Rotondo, Foggia, Italy, 71013
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) – Ospedale Casa Sollievo della Sofferenza (CSS)
Poland
Uniwersyteckie Centrum Kliniczne (UCK)
Contact:
Agnieszka Piekarska, MD
babajaga@gumed.edu.pl
Katowice, Silesia, Poland, Silesia
Slaski Uniwersytet Medyczny (SUM) w Katowicach – Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) – Slaskie Centrum Hematologii I Transplantacji Szpiku
Contact:
Agata Wieczorkiewicz-Kabut
wieczorkiewicza@tlen.pl
Taïwan
Changhua Christian Hospital
Tainan, Taiwan, 70403
National Cheng-Kung University Hospital
Taipei, Taiwan, 10002
National Taiwan University Hospital (NTUH)
France
Contact:
Sylvain Thepot, MD
Sylvain.Thepot@chu-angers.fr
Centre Hospitalier Regional Universitaire (CHRU) de Lille – Hopital Claude Huriez
CHU de Nantes – Hôtel Dieu
Contact:
Patrice Chevallier, MD
patrice.chevallier@chu-nantes.fr
Hospital Saint Antoine
Contact:
Florent Mallard, MD
florent.malard@inserm.fr
Hôpital Saint Louis
Centre de Lutte Contre le Cancer (CLCC) – Institut Gustave-Roussy
Japan
Kobe City Medical Center General Hospital
Contact:
Takayuki Ishikawa, MD
ishikawa@kcho.jp
Sapporo-shi, Japan, 060-8648
Hokkaido University Hospital
Tokyo, Japan
Tokyo Metropolitan Cancer and infection Disese Center Komagome Hospital
Yufu, Japan, 875593
Oita University (OU) Hospital
Osaka-shi, Osaka-Fu, Japan, 545-8589
Osaka Metropolitan University Hospital
Shimotsuke-shi, Tochigi-Ken, Japan, 329-0498
Jichi Medical University (JMU) Hospital
Switzerland
Universitaetsspital Basel
Spain
Hospital Universitari Vall d’Hebron – Institut de Recerca (VHIR)
Barcelona, Spain, 8908
Institut Catala d’Oncologia (ICO)
Contact:
Annalisa Paviglianiti, MD
annalisapaviglianiti@iconcologia.net
Barcelona, Spain, 8916
Institut Catala d’Oncologia (ICO) – Hospital Universitari Germans Trias i Pujol (HUGTP) Location
Granada, Spain
Hospital Universitario Virgen de las Nieves
Contact:
Pedro Gonalez-Sierra, MD
Pedroa.gonzalez.sspa@juntadeandalucia.es
Las Palmas De Gran Canaria, Spain
Hospital Universitario de Gran Canaria “”
Contact:
Melisa Karina Torres Ochando, MD
m.torresochando@gmail.com
Madrid, Spain
Hospital De La Princesa
Madrid, Spain
Hospital Universitario 12 de Octubre
Contact:
Maria Calbacho Robles, MD
maria.calbacho@salud.madrid.org
Madrid, Spain
Hospital Universitario Ramon y Cajal
Salamanca, Spain
Hospital Clinico Universitario – Universidad de Salamanca
Contact:
Estefanía Pérez López, MD
eperezl@saludcastillayleon.es
Valencia, Spain
Hospital Universitari i Politecnic La Fe
Contact:
Jaime Sanz Caballer, MD