Roll-over study for patients who have completed a prior Novartis sponsored sabatolimab (MBG453) study and are judged by the investigator to benefit from continued treatment with sabatolimab
- Conditions
- intermediate, high or very high risk MDS in adult patients chronic Myelomonocytic Leukemia - 2 (CMML-2) Acute Myeloid Leukemia (AML) in adult patients unfit for chemotherapy
- Registration Number
- 2024-515281-14-00
- Lead Sponsor
- Novartis Pharma AG
- Brief Summary
To evaluate safety, including SAE and AE
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 18
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.
Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment.
Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures.
Written informed consent obtained prior to enrolling in the roll-over study.
Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol.
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.
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).
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.
Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol.
Local access to commercially available sabatolimab for parent protocol indications.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency and severity of AEs and SAEs Frequency and severity of AEs and SAEs
- Secondary Outcome Measures
Name Time Method Duration of exposure to sabatolimab Duration of exposure to sabatolimab
Trial Locations
- Locations (14)
Medical Center - University Of Freiburg
🇩🇪Freiburg Im Breisgau, Germany
Universitaet Leipzig
🇩🇪Leipzig, Germany
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milan, Italy
Azienda Ospedaliera Policlinico Universitario Tor Vergata
🇮🇹Rome, Italy
IRCCS Ospedale Policlinico San Martino
🇮🇹Genoa, Italy
Careggi University Hospital
🇮🇹Florence, Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
🇮🇹Brescia, Italy
University General Hospital Of Alexandroupoli
🇬🇷Alexandroupoli, Greece
General University Hospital Of Patras
🇬🇷Patras, Greece
Oncopole Claudius Regaud
🇫🇷Toulouse Cedex 9, France
Scroll for more (4 remaining)Medical Center - University Of Freiburg🇩🇪Freiburg Im Breisgau, GermanyRobert ZeiserSite contact+4976127034580Robert.zeiser@uniklinik-freiburg.de