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

Acute Myeloid Leukemia Clinical Trial

Official title:

A MULTI-CENTER CONTINUATION STUDY EVALUATING AZACITIDINE WITH OR WITHOUT GLASDEGIB (PF-04449913) IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA, MYELODYSPLASTIC SYNDROME OR CHRONIC MYELOMONOCYTIC LEUKEMIA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04842604
• Other study ID #: B1371019 Open Label Extension
• Secondary ID: 2017-002822-19
• Status: Completed
• Phase: Phase 3
• Start date: May 17, 2021
• Est. completion date: December 2, 2022

Study information

• Verified date: November 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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• Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason (including INT cohort participants required to end study treatment)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• Glasdegib
25 mg or 100 mg tablet
• Azacitidine
100 mg/vial powder for 25 mg/mL suspension for injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Canada,  Czechia,  France,  Hungary,  Italy,  Japan,  Mexico,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Event (AE) and Treatment Related AE	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.	From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)
Primary	Number of Participants With Treatment Emergent Serious Adverse Events (SAE) and Treatment Related SAEs	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.	From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)

External Links

•   B1371019 (NCT03416179)