Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT05429632
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2022-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, multicenter, randomized, double-blind, placebo-controlled, and 3-arm parallel group study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 366}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2022-06-17', 'studyFirstSubmitQcDate': '2022-06-17', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-free survival (RFS)', 'timeFrame': '12 months', 'description': 'To compare the efficacy of mocravimod to that of placebo'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '24 months', 'description': "To compare mocravimod's effect on overall survival (OS) to that of placebo"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adult Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, double-blinded, placebo controlled trial.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, \\[CRi\\] is also allowable\n* 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\n* Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5\n* Planned use of TAC-based GvHD prophylaxis\n* age ≥ 18 years and ≤ 75 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* Use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis\n* Diagnosis of macular edema during screening\n* Cardiac/pulmonary/hepatic/renal dysfunction\n* 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\n* Renal dysfunction with estimated creatinine clearance \\< 45 mL/min by the Cockcroft-Gault formula\n\n * Diabetes mellitus\n * History or presence of uveitis at screening\n * History or diagnosis of macular edema'}, 'identificationModule': {'nctId': 'NCT05429632', 'acronym': 'MO-TRANS', 'briefTitle': 'Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Priothera SAS'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Priothera SAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3mg mocravimod arm', 'description': '3 mg of mocravimod orally once per day for 12 months', 'interventionNames': ['Drug: mocravimod']}, {'type': 'EXPERIMENTAL', 'label': '1mg mocravimod arm', 'description': '1 mg of mocravimod orally once per day for 12 months', 'interventionNames': ['Drug: mocravimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'placebo orally once per day for 12 months', 'interventionNames': ['Drug: mocravimod']}], 'interventions': [{'name': 'mocravimod', 'type': 'DRUG', 'description': 'S1PR modulator', 'armGroupLabels': ['1mg mocravimod arm', '3mg mocravimod arm', 'Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-1932', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Antonio Di Stasi, MD', 'role': 'CONTACT', 'email': 'adistasi@uabmc.edu'}], 'facility': 'University of Alabama Hospital (UAB Hospital)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85234-2165', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center - Duarte', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of California Los Angeles (UCLA) - David Geffen School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30322-1013', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edmund Waller, MD', 'role': 'CONTACT', 'email': 'ewaller@emory.edu'}], 'facility': 'Emory University - Winship Cancer Institute (WCI)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '66103', 'city': 'Westwood', 'state': 'Kansas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Ochsner Medical Center (OMC) - New Orleans', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21201-1544', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Maryland Medical Center (UMMC)', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202-2610', 'city': 'Detroit', 'state': 'Michigan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Henry Ford Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sami Brake, MD', 'role': 'CONTACT', 'email': 'Sami.Brake@spectrumhealth.org'}], 'facility': 'Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Huselton, MD', 'role': 'CONTACT', 'email': 'Eric_Huselton@URMC.Rochester.edu'}], 'facility': 'University of Rochester Medical Center (URMC)', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11794-0001', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Fengshuo Lan, MD', 'role': 'CONTACT', 'email': 'Fengshuo.Lan@stonybrookmedicine.edu'}], 'facility': 'Stony Brook University (SBU) - Cancer Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center (University Hospital)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106-1716', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gabriella Pettito, MD', 'role': 'CONTACT', 'email': 'Gabriella.Pettito@uhhospitals.org'}], 'facility': 'The Ohio State University Comprehensive Cancer Center (OSUCCC)', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239-3098', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Arpita Gandhi, MD', 'role': 'CONTACT', 'email': 'gandhiar@ohsu.edu'}], 'facility': 'Oregon Health & Science University (OHSU) - Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104-4206', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Porter, MD', 'role': 'CONTACT', 'email': 'david.porter@uphs.upenn.edu'}], 'facility': 'University of Pennsylvania - Abramson Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Baylor Charles A. Sammons Cancer Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': 'B1884LAD', 'city': 'Buenos Aires', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Argentina', 'facility': 'Hospital El Cruce - Dr. Nestor Kirchner', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Argentina', 'facility': 'Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Córdoba', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Argentina', 'facility': 'Sanatorio Allende (SA) - Nueva Cordoba', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '1900', 'city': 'La Plata', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Argentina', 'facility': 'Hospital Italiano La Plata', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': '88034-000', 'city': 'Florianópolis', 'state': 'Santa Catarina', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Brazil', 'facility': 'CEPON - Centro de Pesquisas Oncologicas', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}, {'zip': '81520-060', 'city': 'Curicica', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Brazil', 'facility': 'Hospital Erasto Gaertner', 'geoPoint': {'lat': -22.95382, 'lon': -43.38384}}, {'zip': '01327-001', 'city': 'São Paulo', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Brazil', 'facility': 'Hospital Alemao Oswaldo Cruz (HAOC)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403-000', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Gian Carlo Fatobene, MD', 'role': 'CONTACT', 'email': 'giancarlo.fatobene@hc.fm.usp.br'}], 'facility': 'Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05652-900', 'city': 'São Paulo', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Brazil', 'facility': 'Hospital Israelita Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '13083-878', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Marcos P Colella, MD', 'role': 'CONTACT', 'email': 'mpc@unicamp.br'}], 'facility': 'Unicamp', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '17210-080', 'city': 'São Paulo', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Brazil', 'facility': 'Hospital Amaral Carvalho', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvain Thepot, MD', 'role': 'CONTACT', 'email': 'Sylvain.Thepot@chu-angers.fr'}], 'facility': 'Centre Hospitalier Universitaire (CHU) Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Lille', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Regional Universitaire (CHRU) de Lille - 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Institut Gustave-Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Halle', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '07747', 'city': 'Jena', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Universitaetsklinikum Jena - Klinik fuer Innere Medizin II', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '04103', 'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Georg-Nikolaus Franke, MP', 'role': 'CONTACT', 'email': 'Georg-Nikolaus.Franke@medizin.uni-leipzig.de', 'phone': '.+49 341 97-13132'}], 'facility': 'University of Leipzig Medical Center', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '81377', 'city': 'Munich', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Tsila Zuckermann, MD', 'role': 'CONTACT', 'email': 't_zuckerman@rambam.health.gov'}], 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Israel', 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ron Ram, MD', 'role': 'CONTACT', 'email': 'ronr@tlvmc.gov.il'}], 'facility': 'The Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Litwinsky', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Avichai Shimoni, MD', 'role': 'CONTACT', 'email': 'avichai.Shimoni@sheba.health.gov.il'}], 'facility': 'The Chaim Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '89133', 'city': 'Reggio Calabria', 'state': 'Calabria', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Grande Ospedale Metropolitano Bianchi Melacrino Morelli', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'zip': '71013', 'city': 'San Giovanni Rotondo', 'state': 'Foggia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Angelo M Carella, MD', 'role': 'CONTACT', 'email': 'am.carella@operapadrepio.it'}], 'facility': 'Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'zip': '15121', 'city': 'Alessandria', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Nazionale SS. 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