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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 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 530 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04266301
The ClinicalTrials.gov registry entry for NCT04266301 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 530 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04266301 reports 0 study locations.
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.
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