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

Phase 3

Completed

Conditions: Chronic Myelomonocytic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome

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 glasdegib.

Recruitment & Eligibility

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Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason (including INT cohort participants required to end study treatment)

Arm && Interventions

Group	Intervention	Description
Participants from B1371019 and B1371012	Glasdegib	Azacitidine will be administered 75 mg/m2/day for 7 days every 28 days on Days 1-7 (±3 days) per local label or per the IP Manual (or SPC). Azacitidine may be administered by SC injection or IV infusion. Alternate dosing schedules to administer the 7 doses to accommodate participant and treatment center availability are allowed. The starting dose regimen will be the same as the most recent regimen received on the B1371019 or B1371012 study. Glasdegib 50, 75 or 100 mg will be orally administered daily and continuously. The starting dose regimen will be the same as the most recent regimen received on the B1371012 or B1371019 study.
Participants from B1371019 and B1371012	Azacitidine	Azacitidine will be administered 75 mg/m2/day for 7 days every 28 days on Days 1-7 (±3 days) per local label or per the IP Manual (or SPC). Azacitidine may be administered by SC injection or IV infusion. Alternate dosing schedules to administer the 7 doses to accommodate participant and treatment center availability are allowed. The starting dose regimen will be the same as the most recent regimen received on the B1371019 or B1371012 study. Glasdegib 50, 75 or 100 mg will be orally administered daily and continuously. The starting dose regimen will be the same as the most recent regimen received on the B1371012 or B1371019 study.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Event (AE) and Treatment Related AE	From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)	AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment emergent if the event occurred during the on-treatment period (regardless of if it was seen prior to the start of treatment). An AE was considered treatment related as assigned by the investigator.
Number of Participants With Treatment Emergent Serious Adverse Events (SAE) and Treatment Related SAEs	From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)	A SAE was defined as any untoward medical occurrence that, at any dose that resulted in death; was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or other medical events as per investigator's judgement. A SAE was considered treatment emergent if the event occurred during the on-treatment period (regardless of if it was seen prior to the start of treatment). A SAE was considered treatment related as assigned by the investigator.

Secondary Outcome Measures

Name	Time	Method

Locations (18): Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU
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Salzburg, Austria
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek
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Debrecen, Hungary
Uniklinikum Salzburg, Landeskrankenhaus Salzburg
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Salzburg, Austria
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
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Debrecen, Hungary
WWCOiT im. M. Kopemlka w Lodzl
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Lodz, Poland
The Royal Marsden NHS Foundation Trust
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Sutton, Surry, United Kingdom
Health Sciences Centre
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Winnipeg, Manitoba, Canada
Klinika hematoonkologie
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Ostrava-Poruba, Czechia
CancerCare Manitoba
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Winnipeg, Manitoba, Canada
Osaka City University Hospital
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Osaka-City, Osaka, Japan
Ustavni lekarna
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Ostrava - Poruba, Czechia
AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia
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Torrette Di Ancona, Ancona, Italy
University of Fukui Hospital
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Yoshida-gun, Fukui, Japan
Instituto Nacional de Cancerología
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México, MÉX, Mexico
CHU de Nantes
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Nantes cedex 1, France
CHU de Nantes Hotel Dieu
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Nantes cedex, France
Hospital Universitari i Politecnic La Fe
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Valencia, Spain
SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi
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Torette Di Ancona, AN, Italy