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NCT05201066 · ClinicalTrials.gov registry record · Phase 2
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.
A Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myelomonocytic, Chronic, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 20
- Study locations
NCT05201066: Active Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myelomonocytic, Chronic, sponsored by Novartis Pharmaceuticals.
NCT05201066 is a Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myelomonocytic, Chronic that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 33 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05201066, a Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myelomonocytic, Chronic, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
An AE is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. An AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any adverse event \[appearance of (or worsening of any pre-existing)\] undesirable sign(s), symptom(s), o
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 |
What the registry record for NCT05201066 still lists
NCT05201066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (88% lower).
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.
NCT05201066 names 20 study sites across 14 states, led by Other, Oregon, Utah.
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.
What interventions are being tested in trial NCT05201066?
The interventions under investigation include: venetoclax (DRUG), azacitidine (DRUG), decitabine (DRUG), spartalizumab (DRUG), sabatolimab (DRUG).
Who is sponsoring clinical trial NCT05201066?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndromes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05201066's enrollment target sits among peer trials
33 117th of 173 higher than 57 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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