Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
NCT04842604 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2023-12-18
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.
Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Chronic Myelomonocytic Leukemia
Interventions
- DRUG
-
Glasdegib
25 mg or 100 mg tablet
- DRUG
-
100 mg/vial powder for 25 mg/mL suspension for injection
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-17
- Primary Completion
- 2022-12-02
- Completion
- 2022-12-02
- FDA Drug
- Yes
Countries
- Austria
- Canada
- Czechia
- France
- Hungary
- Italy
- Japan
- Mexico
- Poland
- Spain
- United Kingdom
Study Locations
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