Overview

This trial is active, not recruiting.

Condition hematologic neoplasms
Sponsor Center for International Blood and Marrow Transplant Research
Collaborator National Marrow Donor Program
Start date October 2010
End date October 2020
Trial size 21932 participants
Trial identifier NCT01362179, LTDFU

Summary

This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized PBSC donors.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm
Observational (non-interventional) study.
Observational (non-interventional) study.

Primary Outcomes

Measure
Incidence of malignant myeloid hematologic disorders
time frame: Post HSCT donation

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: 1. Unrelated donor who donated either unstimulated BM or filgrastim-mobilized PBSC between July 1, 1999 and approximately five years post study activation. 2. 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. 3. Donation was managed by a U.S. NMDP donor center. 4. Signed informed consent for participation in this long-term donor follow-up study. Concurrent enrollment on other studies is permitted. Exclusion Criteria: 1. Unrelated donor who donated filgrastim-mobilized bone marrow. 2. Donation was managed by a non-U.S. donor center. 3. Donor is unable to verbally communicate in any of the following languages: English, Spanish, Mandarin Chinese, Cantonese Chinese, Vietnamese, Korean, or Portuguese.

Additional Information

Official title 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 (rHuG-CSF)
Principal investigator John P Miller, MD, PhD
Description This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized PBSC donors. Donors will undergo biennial surveys until study completion. Cases of targeted disorders will be reviewed by the medical monitors to confirm the veracity of the report.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Center for International Blood and Marrow Transplant Research.