Study identification

EU PAS number

EUPAS19126

Study ID

48970

Official title and acronym

Incidence of Hematologic and Non-Hematologic Malignancies, Thrombotic Events, and Autoimmune Disorders in Unrelated Normal Donors Undergoing Bone Marrow Harvest Versus Peripheral Blood Stem Cell Mobilization with Recombinant Human Granulocyte Colony-Stimulating Factor (20130209)

DARWIN EU® study

No

Study countries

United States

Study description

The National Marrow Donor Program (NMDP) in the USA, through its research program, the Center for International Blood and Marrow Transplant Research (CIBMTR), collects data on outcomes of alloHCT donors and recipients. Both unstimulated BM and filgrastim-mobilized PBSC donors are contacted by the donor center two days post-donation and then weekly until the donor states he or she has recovered. Since 2006, all donors are then contacted annually for as long as possible, unless the donor formally withdraws from long term follow-up. Primary Objective: To describe the long-term incidence of malignant myeloid haematologic disorders in donors who received and in those who did not receive filgrastim. Secondary Objectives: To describe the long-term incidence of haematologic and non-haematologic malignant disorders, thrombotic events, and autoimmune diseases. Study Design/Type: The study is an observational cohort study, including unrelated normal donors who donated haematopoietic cells July 1999 through October 2010 and prospectively enrolled unrelated normal donors who donated haematopoietic cells between 2010 and 2015. Follow-up is approximately five years post study activation. Sample Size: Approximately 90% of the eligible donors are projected to donate during the study accrual period: approximately 10,956 unstimulated BM and 21,172 filgrastim-mobilized PBSC donors. Assuming that the incidence rate of haematological malignancies in the normal population is 1 case per thousand person-years, then this study should have approximately 80% power to detect a rate ratio of 1.25 associated with filgrastim use.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Regulatory

Was the study required by a regulatory body?

Unknown

Is the study required by a Risk Management Plan (RMP)?

Not applicable