Clinical trial NCT04842604: Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-04-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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* Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason (including INT cohort participants required to end study treatment)

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Event (AE) and Treatment Related AE
timeFrame: From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)
measure: Number of Participants With Treatment Emergent Serious Adverse Events (SAE) and Treatment Related SAEs
timeFrame: From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg, Landeskrankenhaus Salzburg
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Ostrava - Poruba
country: Czechia
facility: Ustavni lekarna
city: Ostrava-Poruba
country: Czechia
facility: Klinika hematoonkologie
city: Nantes cedex 1
country: France
facility: CHU de Nantes
city: Nantes cedex
country: France
facility: CHU de Nantes Hotel Dieu
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
city: Torrette Di Ancona
country: Italy
facility: AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia
state: Ancona
city: Torette Di Ancona
country: Italy
facility: SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi
state: AN
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Osaka-City
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: México
country: Mexico
facility: Instituto Nacional de Cancerología
state: MÉX
city: Lodz
country: Poland
facility: WWCOiT im. M. Kopemlka w Lodzl
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surry
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: