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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04842604




Registration number
NCT04842604
Ethics application status
Date submitted
8/04/2021
Date registered
13/04/2021
Date last updated
16/12/2022

Titles & IDs
Public title
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
Scientific 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
Secondary ID [1] 0 0
2017-002822-19
Secondary ID [2] 0 0
B1371019 Open Label Extension
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Myelodysplastic Syndrome 0 0
Chronic Myelomonocytic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Glasdegib
Treatment: Drugs - Azacitidine

Experimental: Participants from B1371019 and B1371012 - 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.


Treatment: Drugs: Glasdegib
25 mg or 100 mg tablet

Treatment: Drugs: Azacitidine
100 mg/vial powder for 25 mg/mL suspension for injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment related adverse events (TEAE)
Timepoint [1] 0 0
Baseline through 28 days after last dose (up to approximately 20 months)
Primary outcome [2] 0 0
Number of participants with serious adverse events (SAE)
Timepoint [2] 0 0
Baseline through 28 days after last dose (up to approximately 20 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/12/2022
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Czechia
State/province [3] 0 0
Ostrava - Poruba
Country [4] 0 0
Czechia
State/province [4] 0 0
Ostrava-Poruba
Country [5] 0 0
France
State/province [5] 0 0
Nantes cedex 1
Country [6] 0 0
France
State/province [6] 0 0
Nantes cedex
Country [7] 0 0
Hungary
State/province [7] 0 0
Debrecen
Country [8] 0 0
Italy
State/province [8] 0 0
Ancona
Country [9] 0 0
Italy
State/province [9] 0 0
AN
Country [10] 0 0
Japan
State/province [10] 0 0
Fukui
Country [11] 0 0
Japan
State/province [11] 0 0
Osaka
Country [12] 0 0
Mexico
State/province [12] 0 0
MÉX
Country [13] 0 0
Poland
State/province [13] 0 0
Lodz
Country [14] 0 0
Spain
State/province [14] 0 0
Valencia
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Surry

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04842604
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries