Recruiting NCT05429632
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mocravimod.
- Who it may be relevant to
- Registry conditions: Adult Acute Myeloid Leukemia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Brazil, France, Germany +9
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Drug mocravimod
S1PR modulator
Primary outcome measures
- Relapse-free survival (RFS) [Time frame: 12 months]
Secondary outcome measures (1)
- Overall survival (OS) [Time frame: 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 21 centers
- University of Alabama Hospital (UAB Hospital) — Birmingham
- Banner MD Anderson Cancer Center — Gilbert
- City of Hope Comprehensive Cancer Center - Duarte — Duarte
- University of California Los Angeles (UCLA) - David Geffen School of Medicine — Los Angeles
- UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center — Aurora
- Moffitt Cancer Center — Tampa
- Emory University - Winship Cancer Institute (WCI) — Atlanta
- University of Iowa Hospitals and Clinics — Iowa City
- … and 13 more centers
Japan · 15 centers
- Anjo-kosei Hospital — Anjo-shi
- Japanese Red Cross Nagoya Daiichi Hospital (First Hospital) — Nagoya
- Kanazawa University Hospital — Kanazawa
- Osaka Metropolitan University Hospital — Osaka
- Jichi Medical University Saitama Medical Center — Saitama
- Jichi Medical University (JMU) Hospital — Shimotsuke-shi
- Kyushu University Hospital, — Fukuoka
- Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital — Hiroshima
- … and 7 more centers
Italy · 12 centers
- Azienda Sanitaria Localedella provincia di Brindisi - — Brindisi
- Grande Ospedale Metropolitano Bianchi Melacrino Morelli — Reggio Calabria
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della — San Giovanni Rotondo
- Ospedale Vito Fazzi Lecce — Lecce
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria — Alessandria
- Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno — Ascoli Piceno
- Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) LAB T — Florence
- … and 4 more centers
France · 10 centers
- Centre Hospitalier Universitaire (CHU) Angers — Angers
- Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez - — Lille
- Centre Hospitalier Lyon-Sud — Lyon
- CHRU Nancy Hopitaux de Brabois — Nancy
- CHU de Nantes - Hôtel Dieu — Nantes
- Hospital Saint Antoine — Paris
- Hôpital Saint Louis — Paris
- Strasbourg (UIC d'onco-hématologie - Hôpital de Hautepierre) — Strasbourg
- … and 2 more centers
Spain · 10 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 10 centers
Center list to be confirmed — check the primary protocol.
Brazil · 7 centers
- CEPON - Centro de Pesquisas Oncologicas — Florianópolis
- Hospital Erasto Gaertner — Curicica
- Hospital Alemao Oswaldo Cruz (HAOC) — São Paulo
- Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina (HCFMUSP) — São Paulo
- Hospital Israelita Albert Einstein — São Paulo
- Unicamp — São Paulo
- Hospital Amaral Carvalho — São Paulo
Germany · 5 centers
- Universitätsklinikum Freiburg — Freiburg im Breisgau
- Universitätsklinikum Halle — Halle
- Universitaetsklinikum Jena - Klinik fuer Innere Medizin II — Jena
- University of Leipzig Medical Center — Leipzig
- LMU Klinikum Grosshadern Klinikum der Universitaet Muenchen — Munich
Poland · 5 centers
- Sp Zoz Szpital Uniwersytecki W Krakowie — Krakow
- Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny i — Katowice
- … and 3 more centers
Argentina · 4 centers
- Hospital El Cruce - Dr. Nestor Kirchner — Buenos Aires
- Centro de Educacion Medica E Investigacines Clinicas Norberto Quirno CEMIC — Buenos Aires
- Sanatorio Allende (SA) - Nueva Cordoba — Córdoba
- Hospital Italiano La Plata — La Plata
Israel · 4 centers
- Rambam Health Care Campus — Haifa
- Hadassah Medical Center — Jerusalem
- The Tel Aviv Sourasky Medical Center — Tel Aviv
- The Chaim Sheba Medical Center — Tel Litwinsky
Taiwan · 4 centers
Center list to be confirmed — check the primary protocol.
Romania · 3 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05429632 · Priothera SAS