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Study was cancelled prior to any enrollment
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Among patients with a diagnosis of AML who received non-intensive chemotherapy:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AML | Patients diagnosed with AML |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azacitidine | Drug | Patients taking azacitidine |
| |
| venetoclax |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was the duration from diagnosis of disease to death. | January 1, 2012 to January 10, 2020 |
| Event Free Survival | Time from the treatment initiation date to the date of treatment failure (TF), relapse from CR or better, or death from any cause, whichever comes first | January 1, 2012 to January 10, 2020 |
| Relapse Free Survival | Time from the treatment initiation date to the date of a relapse event, or death from any cause, whichever comes first | January 1, 2012 to January 10, 2020 |
| Best response | Best response recorded from treatment start until disease progression/recurrence | January 1, 2012 to January 10, 2020 |
| Time to best response | Time from treatment initiation until best response recorded | January 1, 2012 to January 10, 2020 |
| Duration of best response | Time from best response achieved until lose of response or the end of the record, whichever occurs first | January 1, 2012 to January 10, 2020 |
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Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Confirmed diagnosis of AML on or after 01 January 2012 through Clinical Research Nurse (CRN) review of provider documentation of AML diagnosis in the medical record.
Receipt of non-intensive therapy at any point during first line therapy following initial AML diagnosis. For this study, non-intensive therapy will be defined as 1 of the following agents, alone or in combination with any other agent:
Age ≥18 years at initial diagnosis of AML.
Exclusion Criteria:
Patients meeting any of the following criteria will not be included in the study:
1. Record of 1 or more of the following confounding diagnoses at any point before or after AML diagnosis: Acute lymphoblastic leukemia; acute promyelocytic leukemia, aggressive systemic mastocytosis; hypereosinophilic syndrome and/or chronic eosinophilic leukemia; dermatofibrosarcoma protuberans; gastrointestinal stromal tumors.
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This study will include adult patients diagnosed with AML who, at any point during first line therapy, received non-intensive therapy
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C579720 | venetoclax |
| C000592580 | glasdegib |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Drug |
patients taking venetoclax |
|
| glasdegib | Drug | patients taking glasdegib |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |