Phase 3
Completed N=14
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
Source: ClinicalTrials.gov NCT04842604 ↗Enrolled (actual)
14
Serious AEs
21.4%
Results posted
Dec 2023
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Event (AE) and Treatment Related AE — 7; 4; 5; 4 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
An open-label study available to all eligible participants from Study B1371019 and participants originating from Study B1371012 continuing on study intervention with azacitidine with or without glasdegib.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Event (AE) and Treatment Related AE |
7; 4; 5; 4 | — |
| PRIMARY Number of Participants With Treatment Emergent Serious Adverse Events (SAE) and Treatment Related SAEs |
2; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Any participant who continues to demonstrate clinical benefit (as determined by the Principal Investigator) from study treatment with azacitidine with or without glasdegib in this Study or from Study B1371012.
- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion Criteria
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Female participants who are pregnant or breastfeeding (if continuing to receive study intervention);
- Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason (including INT cohort participants required to end study treatment)
Data sourced from ClinicalTrials.gov (NCT04842604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.