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.

Myelodysplastic Syndromes Clinical Trial

Official title: An Open-label, Multicenter, 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.

Status Not yet recruiting

Clinical Trial Summary

This study is intended to collect safety data from participants who completed the parent protocols but are still benefiting from study treatment. The study population consists of participants who tolerate study treatment of the parent studies. Collecting safety information from long-term exposure might offer the unique opportunity to detect rare Adverse Events.

Clinical Trial Description

The purpose of the roll-over study is to provide access and to collect and assess safety of sabatolimab in participants who are currently receiving treatment with sabatolimab in a Novartis-sponsored study (parent study), that has fulfilled the requirements of the primary objective or was terminated for any reason. Eligible participants from those studies who were receiving sabatolimab and who, in the opinion of the investigator, would benefit from continued study treatment, may enroll in the study. The primary objective is to evaluate safety, including serious adverse events (SAE) and adverse events (AE). The secondary objective is to collect exposure to study treatment (sabatolimab and individual combination agents). his is a multicenter, open label, roll-over study to collect and assess safety of sabatolimab in participants who are treated in current Novartis-sponsored parent studies and who are benefitting from continued study treatment including sabatolimab as judged by the investigator. The treatment with sabatolimab and combination agent(s), as applicable, is continued according to the schedule in the parent study. Adverse events will be collected continuously throughout the study and participants will be questioned about adverse events at each visit. Once enrolled in the study, participants may continue study treatment with sabatolimab until occurrence of unacceptable toxicity that precludes further treatment, disease progression, withdrawal of consent, discontinuation at the discretion of the investigator, initiation of a new anticancer therapy and/or discontinuation for any other reason. ;

Related Conditions & MeSH terms

• Leukemia, Myelomonocytic, Chronic
• Myelodysplastic Syndromes

• NCT number: NCT05201066
• Study type: Interventional
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: [email protected]
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 30, 2022
• Completion date: June 13, 2028