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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.
NCT05201066 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG venetoclax
- DRUG azacitidine
- DRUG decitabine
- DRUG spartalizumab
- DRUG sabatolimab
Study Locations (20)
Other
- Novartis Investigative Site — Tianjin
- Novartis Investigative Site — Prague
- Novartis Investigative Site — Toulouse
- Novartis Investigative Site — Alexandroupoli
- Novartis Investigative Site — Pátrai
- Novartis Investigative Site — Fukushima
- Novartis Investigative Site — Kuala Lumpur
Oregon
- Oregon Health Sciences University — Portland
Utah
- Huntsman Cancer Institute Univ of Utah — Salt Lake City
Victoria
- Novartis Investigative Site — Clayton
Santa Catarina
- Novartis Investigative Site — Florianópolis
British Columbia
- Novartis Investigative Site — Vancouver
Jilin
- Novartis Investigative Site — Changchun
Baden-Wurttemberg
- Novartis Investigative Site — Freiburg im Breisgau
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2023-02-13 |
| Est. Completion | 2028-02-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05201066
The ClinicalTrials.gov registry entry for NCT05201066 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 5 interventions — of which venetoclax is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05201066 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Oregon, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05201066 about?
NCT05201066 is a clinical study titled "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.". 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 mi...
What is the current status of trial NCT05201066?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2023-02-13. Estimated completion is 2028-02-14.
What conditions does trial NCT05201066 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05201066?
The interventions under investigation include: venetoclax (DRUG), azacitidine (DRUG), decitabine (DRUG), spartalizumab (DRUG), sabatolimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05201066?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05201066 being conducted?
This trial has 20 study locations across Oregon, Utah, Victoria, Santa Catarina, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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