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
- Myelodysplastic SyndromesLeukemia, Myelomonocytic, Chronic
- Registration Number
- NCT05201066
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria:<br><br> 1. Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is<br> being treated with sabatolimab, and has fulfilled all requirements in the parent<br> study.<br><br> 2. Participant is currently benefiting from the treatment with sabatolimab as<br> determined by guidelines of the parent protocol and investigator's judgment.<br><br> 3. Participant has demonstrated compliance, as assessed by the investigator, with the<br> parent study protocol requirements.<br><br> 4. Willingness and ability to comply with scheduled visits, treatment plan and any<br> other study procedures.<br><br> 5. Written informed consent obtained prior to enrolling in the roll-over study.<br><br>Exclusion Criteria:<br><br> 1. Participants in cohorts or treatment groups not receiving sabatolimab in the parent<br> protocol.<br><br> 2. Participant has been permanently discontinued from sabatolimab treatment in the<br> parent study due to unacceptable toxicity, non-compliance to study procedures,<br> withdrawal of consent or any other reason.<br><br> 3. Participant currently has unresolved toxicities for which sabatolimab dosing has<br> been interrupted in the parent study (participants meeting all other eligibility<br> criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing<br> to resume).<br><br> 4. Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a<br> female after conception confirmed by a positive serum hCG laboratory test and until<br> the termination of gestation.<br><br> 5. Participant not willing to comply with the contraception requirements outlined in<br> the exclusion criteria of the parent protocol.<br><br> 6. Local access to commercially available sabatolimab for parent protocol indications.<br><br>Other protocol-defined Inclusion/Exclusion may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs);Severity of AEs and SAEs
- Secondary Outcome Measures
Name Time Method Duration of exposure to sabatolimab