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)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Neupogen
• Medical condition to be studied:
  Haematopoietic stem cell mobilisation

Population studied

• Short description of the study population:
  The study participants are unrelated donors from the U.S. who received unstimulated bone marrow or filgrastim-mobilized peripheral blood stem cell (PBSC) donation from the National Marrow Donor Program (NMDP) between July 1999 and about five years post-activation in 2010. The study also includes those who received at least one injection of filgrastim during this timeframe but did not collect the cells.; ; Inclusion criteria: ; • Unrelated donor who donated either unstimulated BM or filgrastim-mobilized PBSC between July 1, 1999 and approximately five years post study activation ; • Unrelated donor who received at least one injection of filgrastim or more, but did not donate filgrastim-mobilized PBSC between July 1, 1999 and approximately five years post study activation ; • Donation was managed by a U.S. NMDP donor centre ; • Signed informed consent from the donor for participation in this long-term donor follow-up study ; • Concurrent enrolment on other studies is permitted; ; Exclusion criteria: ; • Unrelated donor who donated filgrastim-mobilized bone marrow ; • Donation was managed by a non-U.S. donor centre ; • Donor is unable to verbally communicate in any of the following languages: English, Spanish, Mandarin Chinese, Cantonese Chinese, Vietnamese, Korean or Portuguese
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with haematopoietic stem cell mobilisation
• Estimated number of subjects:
  32128

Study design details

• Main study objective:
  The primary goal is to evaluate the hypothesis that the incidence of targeted disorders, consisting of malignant, thrombotic and autoimmune disorders, after unrelated hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized PBSC donors.
• Outcomes:
  Malignant disorders include AML, MDS, CML, chronic myeloproliferative disorders, acute lymphoblastic leukemia, chronic lymphocytic leukemia, lymphomas and non-hematologic malignancies, as defined in the Surveillance Epidemiology and End Results (SEER). thrombotic and autoimmune disorders. Autoimmune events include rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, scleroderma, vasculidities, multiple sclerosis and ITP
• Data analysis plan:
  NA