Symptoms and General Pathology

All Conditions

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Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

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Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

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Myeloid Leukemia

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Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

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Juvenile Myelomonocytic Leukemia

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Antimetabolites

Enzyme Inhibitors

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.

Glasdegib

100 mg/vial powder for 25 mg/mL suspension for injection

Pfizer CT.gov Call Center

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.

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

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

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.

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.

Pfizer

Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.

Participants received glasdegib 100 milligrams (mg) tablet per oral (PO) once a day (QD) in combination with azacitidine 75 mg per meter squared (m\^2)/day as subcutaneous (SC) injection or intravenous (IV) infusion for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment.

Glasdegib + Azacitidine

Participants received placebo matched to Glasdegib in combination with azacitidine 75mg/m\^2/day SC or IV for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment.

Placebo + Azacitidine

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Safety analysis set included all participants who receive at least one dose of study treatment.

Pfizer ClinicalTrials.gov Call Center

Treatment emergent AE

Treatment related AE

Number of Participants With Treatment Emergent Adverse Event (AE) and Treatment Related AE

Treatment emergent SAEs

Treatment related SAEs

Number of Participants With Treatment Emergent Serious Adverse Events (SAE) and Treatment Related SAEs

Overall Study

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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