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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.
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.

NCT05201066

Active Not RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic

Interventions: decitabine, spartalizumab, sabatolimab, azacitidine, venetoclax

Countries: United States, Australia, Brazil, Canada, China, Czechia, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. 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.
2. Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment.
3. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
4. Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures.
5. Written informed consent obtained prior to enrolling in the roll-over study.

Exclusion Criteria:

1. Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol.
2. 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.
3. 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).
4. 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.
5. Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol.
6. Local access to commercially available sabatolimab for parent protocol indications.

Other protocol-defined Inclusion/Exclusion may apply.
Locations (24)
  • Portland, Oregon, United States
  • Salt Lake City, Utah, United States
  • Clayton, Victoria, Australia
  • Florianópolis, Santa Catarina, Brazil
  • Vancouver, British Columbia, Canada
  • Changchun, Jilin, China
  • Tianjin, China
  • Prague, Czechia
  • Toulouse, France
  • Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Alexandroupoli, Greece
  • Pátrai, Greece
  • Brescia, BS, Italy
  • Florence, FI, Italy
  • Genova, GE, Italy
  • Milan, MI, Italy
  • Roma, RM, Italy
  • Fukushima, Japan
  • Kuala Lumpur, Malaysia
  • Badalona, Barcelona, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Zurich, Switzerland
  • Izmir, Turkey (Türkiye)