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NCT04266301 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 530
- Enrollment target
NCT04266301: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04266301 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 530 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04266301, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 530 participants
- Enrollment target
Study Summary
This was a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult participants with intermediate, high or very high-risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator. The purpose of the current study was to assess clinical effects of MBG453 in combination with azacytidine in adult participants with IPSS-R intermediate, high, very high risk MDS and CMML-2.
Primary Outcome
OS is the time from randomization until death due to any cause.
Interventions
- DRUG Placebo
- DRUG Azacitidine
- DRUG Sabatolimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2024-10-02 |
| Phase | Phase 3 |
Why NCT04266301 stopped before completion
NCT04266301 is an interventional study that assigns participants to a tested intervention. The registered 530 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04266301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04266301 about?
NCT04266301 is a clinical study titled "Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)". This was a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult participants with intermediate, high or very high-risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (...
What is the current status of trial NCT04266301?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2020-06-08. Estimated completion is 2024-10-02.
What interventions are being tested in trial NCT04266301?
The interventions under investigation include: Placebo (DRUG), Azacitidine (DRUG), Sabatolimab (DRUG).
Who is sponsoring clinical trial NCT04266301?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04266301's enrollment target sits among peer trials
530 706th of 2000 higher than 1,292 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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