Overview

This trial is active, not recruiting.

Condition related hematopoietic stem cell donors
Sponsor Center for International Blood and Marrow Transplant Research
Collaborator National Institutes of Health (NIH)
Start date January 2010
End date January 2016
Trial size 2300 participants
Trial identifier NCT00948636, 06-DON

Summary

The study tests the hypothesis that related hematopoietic stem cell donors are at a higher risk for acute medical and psychological toxicity associated with the donation process compared to adult unrelated hematopoietic stem cell donors.

The study will also assess the hypothesis that young (<18 years) and older (>60 years) related donors are at increased risk for toxicity associated with donation compared to younger adult donors by describing the adverse events reported in these populations.

An ancillary study of the psychological impact of donation on health-related quality of life (HRQoL) will enroll related donors and compare them to an age-matched normative cohort.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Related Hematopoietic Stem Cell Donors

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Donors of any age providing either a first or second BM or PBSC donation - Meet donation criteria per institution policies and procedures - Willing to receive phone follow-up at 1, 6, and 12 months - Signed informed consent for study participation For the HRQoL ancillary study, inclusion criteria: - Related donors age greater than or equal to 5, eligible and consented to the primary trial by the above listed inclusion criteria - Donors competent to answer psychological assessment questions by themselves, or if a child, should be able to respond to psychological assessment questions and have an appropriate proxy also able to complete the HRQoL proxy interview - English speaking - Access to a telephone - Willing to participate in pre-donation, 1 month and 1 year follow-up interviews - Signed informed consent for study participation in ancillary study Exclusion Criteria: - Per institutional guidelines - Donors providing unstimulated peripheral blood stem cells or lymphocytes For the HRQoL ancillary study, exclusion criteria: - Children less than or equal to 4 years of age

Additional Information

Official title A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life
Principal investigator Michael A Pulsipher, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Center for International Blood and Marrow Transplant Research.