Status:
ACTIVE_NOT_RECRUITING
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.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Myelodysplastic Syndromes
Leukemia, Myelomonocytic, Chronic
Eligibility:
All Genders
12-99 years
Phase:
PHASE2
Brief 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 tole...
Detailed Description
This 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 benefiting from ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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, non-compliance 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.
- Other protocol-defined Inclusion/Exclusion may apply.
Key Trial Info
Start Date :
February 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2028
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05201066
Start Date
February 13 2023
End Date
February 14 2028
Last Update
January 7 2026
Active Locations (24)
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1
Oregon Health Sciences University
Portland, Oregon, United States, 97239
2
Huntsman Cancer Institute Univ of Utah
Salt Lake City, Utah, United States, 84112 0550
3
Novartis Investigative Site
Clayton, Victoria, Australia, 3168
4
Novartis Investigative Site
Florianópolis, Santa Catarina, Brazil, 88020-210