Overview

Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML

Status:
Active, not recruiting

Trial end date:
2022-12-16

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Azacitidine

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- Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason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)