Status:
COMPLETED
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
Lead Sponsor:
Pfizer
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 glasde...
Eligibility Criteria
Inclusion
- 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
- 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- Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason (including INT cohort participants required to end study treatment)
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04842604
Start Date
May 17 2021
End Date
December 2 2022
Last Update
December 18 2023
Active Locations (18)
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1
Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU
Salzburg, Austria, 5020
2
Uniklinikum Salzburg, Landeskrankenhaus Salzburg
Salzburg, Austria, 5020
3
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
4
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9