Association Between Granulocyte Colony Stimulating Factor (G-CSF) use and Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) Among Elderly Patients With Breast (Stage I-III), lung (Stage I-III) or Prostate (Stage I-IV) Cancer

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39702
• EU PAS number:
  EUPAS19718
• Study ID:
  39702
• Official title and acronym:
  Association Between Granulocyte Colony Stimulating Factor (G-CSF) use and Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) Among Elderly Patients With Breast (Stage I-III), lung (Stage I-III) or Prostate (Stage I-IV) Cancer
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  To describe the treated breast, lung, and prostate cancer population aged 66 years and over, Estimate the risk of MDS/AML for patients, and compare the risk of MDS/AML by treatment modality, chemotherapy regimen and G-CSF prophylaxis
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 31/07/2017

Actual: 31/07/2017

Study start date

Planned: 31/07/2018

Actual: 31/07/2018

Data analysis start date

Planned: 30/04/2019

Actual: 26/04/2019

Date of final study report

Planned: 31/03/2020

Actual: 30/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc

Study protocol

Initial protocol

20160176_01.02.06 Public Redacted Protocol Ver 1.0 2018-08-22 English

Updated protocol

20160176_01.02.06 Public Redacted Protocol Ver 1.0 2019-01-10 English

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)