Clinical trial • Phase I • Oncology
BLEXIMENIB for Acute Myeloid Leukemia
Phase I trial of BLEXIMENIB for Acute Myeloid Leukemia. adaptive. 60 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Acute Myeloid Leukemia
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 01-02-2024
- First CTIS Authorization Date
- 18-03-2024
Trial design
adaptive Phase I trial across 22 sites in France, Germany, Italy and others.
- Adaptive
- True: Dose-finding/dose-escalation design to determine recommended RP2D candidate(s) followed by dose-expansion cohorts to further evaluate safety and tolerability at the RP2D(s).
- Biomarker Stratified
- True: KMT2A, NPM1, NUP98, NUP214
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 60
Eligibility
Recruits 60 paediatric patients.
- Pregnancy Exclusion
- A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
- Vulnerable Population
- Vulnerable population selected. Informed consent required: "Must sign an informed consent form (ICF) indicating participant (or their LAR) understands the purpose of the study and procedures required for the study and is willing to participate in the study." Consent may be provided by the participant or their legally authorised representative (LAR). Paediatric sites are included (paediatric oncology departments listed), indicating additional vulnerable-subject considerations.
Inclusion criteria
- {"criterion_text":"- Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novo or secondary AML; b) relapsed /refractory (Arm A only); c) harboring NPM1, KMT2A, NUP98, or NUP214 alterations"}
- {"criterion_text":"- Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to <=25 x 10^9 per liter (/L), adequate liver and renal function"}
- {"criterion_text":"- ECOG performance status grade of 0, 1 or 2"}
- {"criterion_text":"- A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment"}
- {"criterion_text":"- Must sign an informed consent form (ICF) indicating participant (or their LAR) understands the purpose of the study and procedures required for the study and is willing to participate in the study."}
- {"criterion_text":"- Willing and able to adhere to the prohibitions and restrictions specified in this protocol"}
Exclusion criteria
- {"criterion_text":"- 1. Acute promyelocytic leukemia diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to WHO 2016 criteria"}
- {"criterion_text":"- 2. Leukemic involvement of the central nervous system"}
- {"criterion_text":"- 3. Recipient of solid organ transplant"}
- {"criterion_text":"- 5. Cardiovascular disease that is uncontrolled, increases risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment"}
- {"criterion_text":"- Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less."}
- {"criterion_text":"- Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Incidence and severity of AEs, including DLTs","definition_or_measurement_approach":""}
- {"endpoint_text":"- 2. Incidence and severity of Aes","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 86
- Recruitment Window Months
- 46
- Consent Approach
- Must sign an informed consent form (ICF) indicating participant (or their LAR) understands the purpose of the study and procedures required for the study and is willing to participate in the study.
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 86
France
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 30-09-2025
- Processing Time Days
- 636
- Number Of Sites
- 5
- Number Of Participants
- 18
Sites
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Hematology
- Principal Investigator Name
- Christian Recher
- Principal Investigator Email
- Recher.Christian@iuct-oncopole.fr
- Contact Person Name
- Christian Recher
- Contact Person Email
- Recher.Christian@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Hematology
- Principal Investigator Name
- Emmanuel Gyan
- Principal Investigator Email
- E.GYAN@chu-tours.fr
- Contact Person Name
- Emmanuel Gyan
- Contact Person Email
- E.GYAN@chu-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Hopital Pontchaillou - Hématologie
- Principal Investigator Name
- Tony MARCHAND
- Principal Investigator Email
- tony.marchand@chu-rennes.fr
- Contact Person Name
- Tony MARCHAND
- Contact Person Email
- tony.marchand@chu-rennes.fr
- Site Name
- Institut Paoli-Calmettes
- Department Name
- Hématologie
- Principal Investigator Name
- Sylvain Garciaz
- Principal Investigator Email
- garciazs@ipc.unicancer.fr
- Contact Person Name
- Sylvain Garciaz
- Contact Person Email
- garciazs@ipc.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pediatric hematology and oncology
- Principal Investigator Name
- PETIT Arnaud
- Principal Investigator Email
- arnaud.petit@aphp.fr
- Contact Person Name
- PETIT Arnaud
- Contact Person Email
- arnaud.petit@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 30-09-2025
- Processing Time Days
- 636
- Number Of Sites
- 7
- Number Of Participants
- 25
Sites
- Site Name
- Universitaet Leipzig
- Department Name
- Med. Klinik-Poliklinik I-Hamatologie-Zelltherapie, Hamostaseologie Early Clinical Trials Unit
- Principal Investigator Name
- Madlen Jentzsch
- Principal Investigator Email
- madlen.jentzsch@medizin.uni-leipzig.de
- Contact Person Name
- Madlen Jentzsch
- Contact Person Email
- madlen.jentzsch@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Medizinischen Klinik V Haematologie, Onkologie und Rheumatologie
- Principal Investigator Name
- Tim Sauer
- Principal Investigator Email
- tim.sauer@med.uni-heidelberg.de
- Contact Person Name
- Tim Sauer
- Contact Person Email
- tim.sauer@med.uni-heidelberg.de
- Site Name
- Technische Universitat Dresden
- Department Name
- Medizinische Klinik und Poliklinik I. Haematologie, Zelltherapie und medizinische Onkologie
- Principal Investigator Name
- Christoph Roellig
- Principal Investigator Email
- christoph.roellig@uniklinikum-dresden.de
- Contact Person Name
- Christoph Roellig
- Contact Person Email
- christoph.roellig@uniklinikum-dresden.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Kinder- und Jugendmedizin; Paediatrische Onkologie
- Principal Investigator Name
- Miriam Erlacher
- Principal Investigator Email
- Miriam.Erlacher@uniklinik-ulm.de
- Contact Person Name
- Miriam Erlacher
- Contact Person Email
- Miriam.Erlacher@uniklinik-ulm.de
- Site Name
- Universitaet Leipzig
- Department Name
- Zentrum fuer Frauen- u. Kindermedizin, Abt. fuer paediatrische Onkologie, Haematol. u. Haemostaseol
- Principal Investigator Name
- Lars Fischer
- Principal Investigator Email
- lars.fischer@medizin.uni-leipzig.de
- Contact Person Name
- Lars Fischer
- Contact Person Email
- lars.fischer@medizin.uni-leipzig.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik m.S. Haematologie, Onkologie und Tumorimmunologie
- Principal Investigator Name
- Marie Luise Huetter-Kroenke
- Principal Investigator Email
- luise.huetter-kroenke@charite.de
- Contact Person Name
- Marie Luise Huetter-Kroenke
- Contact Person Email
- luise.huetter-kroenke@charite.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Innere Medizin III Zentrum für Innere Medizin
- Principal Investigator Name
- Hartmut Doehner
- Principal Investigator Email
- hartmut.doehner@uniklinik-ulm.de
- Contact Person Name
- Hartmut Doehner
- Contact Person Email
- hartmut.doehner@uniklinik-ulm.de
Italy
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 01-10-2025
- Processing Time Days
- 637
- Number Of Sites
- 4
- Number Of Participants
- 13
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Unità Operativa di Ematologia – Pad. 8
- Principal Investigator Name
- Cristina Papayannidis
- Principal Investigator Email
- cristina.papayannidis@gmail.com
- Contact Person Name
- Cristina Papayannidis
- Contact Person Email
- cristina.papayannidis@gmail.com
- Site Name
- Azienda Ospedaliera Ospedale Niguarda Ca Granda
- Department Name
- Struttura Complessa di Ematologia
- Principal Investigator Name
- Valeria Mancini
- Principal Investigator Email
- valentina.mancini@ospedaleniguarda.it
- Contact Person Name
- Valeria Mancini
- Contact Person Email
- valentina.mancini@ospedaleniguarda.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Struttura Semplice Dipartimentale (SSD) Ematologia
- Principal Investigator Name
- Marianna Norata
- Principal Investigator Email
- marianna.norata@irst.emr.it
- Contact Person Name
- Marianna Norata
- Contact Person Email
- marianna.norata@irst.emr.it
- Site Name
- Humanitas Research Hospital
- Department Name
- U.O. di Oncologia Medica ed Ematologia
- Principal Investigator Name
- Matteo Giovanni Della Porta
- Principal Investigator Email
- matteo.della_porta@hunimed.eu
- Contact Person Name
- Matteo Giovanni Della Porta
- Contact Person Email
- matteo.della_porta@hunimed.eu
Spain
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 03-10-2025
- Processing Time Days
- 639
- Number Of Sites
- 6
- Number Of Participants
- 30
Sites
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Principal Investigator Name
- Ana Alfonso
- Principal Investigator Email
- aalfonso@unav.es
- Contact Person Name
- Ana Alfonso
- Contact Person Email
- aalfonso@unav.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hematology
- Principal Investigator Name
- Gala Vega
- Principal Investigator Email
- gala.vega@startmadrid.com
- Contact Person Name
- Gala Vega
- Contact Person Email
- gala.vega@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Principal Investigator Name
- Olga Salamero
- Principal Investigator Email
- osalamero@vhio.net
- Contact Person Name
- Olga Salamero
- Contact Person Email
- osalamero@vhio.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Principal Investigator Name
- Jordi Esteve
- Principal Investigator Email
- jesteve@clinic.cat
- Contact Person Name
- Jordi Esteve
- Contact Person Email
- jesteve@clinic.cat
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Hematology
- Principal Investigator Name
- Ana Garrido
- Principal Investigator Email
- AGarridoD@santpau.cat
- Contact Person Name
- Ana Garrido
- Contact Person Email
- AGarridoD@santpau.cat
- Site Name
- Hospital Infantil Universitario Nino Jesus
- Department Name
- Hematology
- Principal Investigator Name
- Alba Rubio
- Principal Investigator Email
- alba.rubio@salud.madrid.org
- Contact Person Name
- Alba Rubio
- Contact Person Email
- alba.rubio@salud.madrid.org
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- code:6
- Name
- Parexel International (IRL) Limited
- Responsibilities
- code:6
- Name
- Ppd Inc.
- Responsibilities
- code:4
- Name
- Pharmaceutical Research Associates Group B.V.
- Responsibilities
- code:4
- Name
- 4g Clinical LLC
- Responsibilities
- code:3
Third parties
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"code:15; Provision of supplies for refrigerated IP transportation from site to subjects houses","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code:15; Lab kits and collection services for PK samples","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Hematogenix Laboratory Services Limited","duties_or_roles":"code:15; Lab kits and collection services for PD samples","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"code:13; code:15; Central ECG analysis","organisation_type":"Pharmaceutical company"}
- {"country":"Malaysia","full_name":"Hematogenix","duties_or_roles":"code:15; Lab kits and collection services for PD samples","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"code:13; code:15; Central ECG analysis","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- JNJ-75276617
- Active Substance
- BLEXIMENIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- 1
- Investigational Product Name
- Cytarabine 100 mg/ml Solution for Injection or Infusion
- Active Substance
- CYTARABINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- 2
- Investigational Product Name
- Idarubicin
- Active Substance
- IDARUBICIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- 1
- Investigational Product Name
- Daunoblastin® (Daunorubicin)
- Active Substance
- DAUNORUBICIN HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- 2
- Investigational Product Name
- Azacitidine
- Active Substance
- AZACITIDINE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- 1
- Investigational Product Name
- Venclyxto (Venetoclax)
- Active Substance
- VENETOCLAX
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- 2
- Combination Treatment
- Yes
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