Clinical trial • Phase II • Oncology
SABATOLIMAB for Myelodysplastic syndromes (MDS) | Chronic myelomonocytic leukemia (CMML-2) | Acute myeloid leukemia (AML)
Phase II trial of SABATOLIMAB for Myelodysplastic syndromes (MDS) | Chronic myelomonocytic leukemia (CMML-2) | Acute myeloid leukemia (AML).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Myelodysplastic syndromes (MDS) | Chronic myelomonocytic leukemia (CMML-2) | Acute myeloid leukemia (AML)
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody | Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 13-08-2024
- First CTIS Authorization Date
- 16-09-2024
Trial design
open-label, none/not specified-controlled Phase II trial across 12 sites in Spain, Greece, France and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 27
Eligibility
Recruits 27 paediatric patients.
- Pregnancy Exclusion
- Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation.
- Vulnerable Population
- Vulnerable population selected. The trial includes provisions for minors/adolescents (Adolescent Assent and Parent/Legal Guardian consent forms are present). Written informed consent is required prior to enrolment; where participants are minors an assent form plus parent/legal guardian consent is provided.
Inclusion criteria
- {"criterion_text":"- Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is being treated with sabatolimab, and has fulfilled all requirements in the parent study."}
- {"criterion_text":"- Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment."}
- {"criterion_text":"- Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements."}
- {"criterion_text":"- Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures."}
- {"criterion_text":"- Written informed consent obtained prior to enrolling in the roll-over study."}
Exclusion criteria
- {"criterion_text":"- Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol."}
- {"criterion_text":"- Participant has been permanently discontinued from sabatolimab treatment in the parent study due to unacceptable toxicity, noncompliance to study procedures, withdrawal of consent or any other reason."}
- {"criterion_text":"- Participant currently has unresolved toxicities for which sabatolimab dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing to resume)."}
- {"criterion_text":"- Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation."}
- {"criterion_text":"- Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol."}
- {"criterion_text":"- Local access to commercially available sabatolimab for parent protocol indications."}
- {"criterion_text":"- (other exclusion criteria not provided in the Part I principalExclusionCriteria list)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Frequency and severity of AEs and SAEs","definition_or_measurement_approach":"Assessment of frequency and severity of adverse events (AEs) and serious adverse events (SAEs) as reported during exposure to sabatolimab (no further measurement detail provided in the Part I data)."}
Secondary endpoints
- {"endpoint_text":"- Duration of exposure to sabatolimab","definition_or_measurement_approach":"Collection of duration of exposure (time on treatment) to sabatolimab (no further measurement detail provided in the Part I data)."}
Recruitment
- Planned Sample Size
- 27
- Recruitment Window Months
- 60
- Consent Approach
- Written informed consent is required prior to enrolment. Age-specific documents are provided: adult ICFs, Parent/Legal Guardian consent forms and Adolescent assent forms. ICFs/assent documents are available in multiple languages (examples in the dossier include German, French, Italian, Spanish, Czech, Greek and English).
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 18
Spain
- Earliest CTIS Part Ii Submission Date
- 09-09-2024
- Latest Decision Or Authorization Date
- 04-06-2025
- Processing Time Days
- 268
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- 1803: Hematología
- Principal Investigator Name
- Blanca Xicoy Cirici
- Principal Investigator Email
- bxicoy@iconcologia.net
- Contact Person Name
- Blanca Xicoy Cirici
- Contact Person Email
- bxicoy@iconcologia.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- 1800: Hematología
- Principal Investigator Name
- Jordi Esteve Reyner
- Principal Investigator Email
- JESTEVE@clinic.cat
- Contact Person Name
- Jordi Esteve Reyner
- Contact Person Email
- JESTEVE@clinic.cat
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- 1805: Hematología
- Principal Investigator Name
- Patricia Font Lopez
- Principal Investigator Email
- patricia.font@salud.madrid.org
- Contact Person Name
- Patricia Font Lopez
- Contact Person Email
- patricia.font@salud.madrid.org
Greece
- Earliest CTIS Part Ii Submission Date
- 09-09-2024
- Latest Decision Or Authorization Date
- 30-09-2025
- Processing Time Days
- 386
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- General University Hospital Of Patras
- Department Name
- 1300: Hematology Division, Hematology Department
- Principal Investigator Name
- Alexandros Spyridonidis
- Principal Investigator Email
- spyridonidis@upatras.gr
- Contact Person Name
- Alexandros Spyridonidis
- Contact Person Email
- spyridonidis@upatras.gr
- Site Name
- University General Hospital Of Alexandroupoli
- Department Name
- 1301: Hematology
- Principal Investigator Name
- Ioannis Kotsianidis
- Principal Investigator Email
- ikotsian@med.duth.gr
- Contact Person Name
- Ioannis Kotsianidis
- Contact Person Email
- ikotsian@med.duth.gr
France
- Earliest CTIS Part Ii Submission Date
- 09-09-2024
- Latest Decision Or Authorization Date
- 02-06-2025
- Processing Time Days
- 266
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Oncopole Claudius Regaud
- Department Name
- 1001: 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
Czechia
- Earliest CTIS Part Ii Submission Date
- 09-09-2024
- Latest Decision Or Authorization Date
- 03-06-2025
- Processing Time Days
- 267
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- 1100: I. Interní klinika - klinika hematologie
- Principal Investigator Name
- Anna Jonášová
- Principal Investigator Email
- anna.jonasova@vfn.cz
- Contact Person Name
- Anna Jonášová
- Contact Person Email
- anna.jonasova@vfn.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 09-09-2024
- Latest Decision Or Authorization Date
- 20-09-2024
- Processing Time Days
- 11
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- 2211: Klinik fuer Innere Medizin I
- Principal Investigator Name
- Robert Zeiser
- Principal Investigator Email
- Robert.zeiser@uniklinik-freiburg.de
- Contact Person Name
- Robert Zeiser
- Contact Person Email
- Robert.zeiser@uniklinik-freiburg.de
- Site Name
- Universitaet Leipzig
- Department Name
- 2200: Klinik und Poliklinik fuer Haematologie, Zelltherapie und Haemostaseologie
- Principal Investigator Name
- Uwe Platzbecker
- Principal Investigator Email
- uwe.platzbecker@medizin.uni-leipzig.de
- Contact Person Name
- Uwe Platzbecker
- Contact Person Email
- uwe.platzbecker@medizin.uni-leipzig.de
Italy
- Earliest CTIS Part Ii Submission Date
- 09-09-2024
- Latest Decision Or Authorization Date
- 09-07-2025
- Processing Time Days
- 303
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- 2404: Oncoematologia
- Principal Investigator Name
- Adriano Venditti
- Principal Investigator Email
- adriano.venditti@uniroma2.it
- Contact Person Name
- Adriano Venditti
- Contact Person Email
- adriano.venditti@uniroma2.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- 2408: U.S.D. Trapianto Midollo Osseo per Adulti
- Principal Investigator Name
- Domenico Russo
- Principal Investigator Email
- domenico.russo@unibs.it
- Contact Person Name
- Domenico Russo
- Contact Person Email
- domenico.russo@unibs.it
- Site Name
- Careggi University Hospital
- Department Name
- 2403: Hematology
- Principal Investigator Name
- Valeria Santini
- Principal Investigator Email
- valeria.santini@unifi.it
- Contact Person Name
- Valeria Santini
- Contact Person Email
- valeria.santini@unifi.it
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties codes: 1
- Name
- Syneos Health Inc.
- Responsibilities
- sponsorDuties codes: 1
- Name
- PRA Hellas CRO A.E.
- Responsibilities
- sponsorDuties codes: 1
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties codes: 12
- Name
- Medidata Solutions International Limited
- Responsibilities
- sponsorDuties codes: 15 (quality control); 6
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: 1; 15 (drug dispensing/reconciliation cycle visits); 3
- Name
- Opis S.r.l.
- Responsibilities
- sponsorDuties codes: 15 (TMF archive)
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"sponsorDuties codes: 15 (TMF archive)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 12","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"sponsorDuties codes: 15 (quality control); 6","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1; 15 (drug dispensing/reconciliation cycle visits); 3","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MBG453
- Active Substance
- SABATOLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- euMpNumber: PRD7812649, prodAuthStatus: 1
- Maximum Dose
- 800 mg
- Investigational Product Name
- VENETOCLAX
- Active Substance
- VENETOCLAX
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- marketingAuthNumber: - , prodAuthStatus: 2
- Maximum Dose
- 400 mg
- Investigational Product Name
- AZACITIDINE
- Active Substance
- AZACITIDINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
- Route
- INTRAVENOUS or SUBCUTANEOUS
- Authorisation Status
- euMpNumber: SUB05624MIG, prodAuthStatus: 2
- Maximum Dose
- 75 mg/m2
- Combination Treatment
- Yes
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