Real-World Observational Study of Outcomes for Acute Myeloid Leukemia (AML) Patients Treated With Glasdegib or Venetoclax in US Community Oncology Practices

Study identification

• EU PAS number:
  EUPAS37385
• Study ID:
  43120
• Official title and acronym:
  Real-World Observational Study of Outcomes for Acute Myeloid Leukemia (AML) Patients Treated With Glasdegib or Venetoclax in US Community Oncology Practices
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Glasdegib (GLAS) and venetoclax (VEN) were approved in November 2018 for the treatment of AML in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy. Limited real-world observational studies of treatment patterns and outcomes for patients treated with either therapy have been conducted.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:24/07/2019

Actual:24/07/2019

Study start date

Planned:30/09/2020

Actual:30/09/2020

Data analysis start date

Planned:09/12/2020

Actual:09/12/2020

Date of final study report

Planned:17/02/2021

Actual:11/05/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer inc

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

B1371039