Stem Cell Related Donor Safety Study

Completed

Conditions studied: Related Hematopoietic Stem Cell Donors

In brief

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.

Key facts

Study ID

NCT00948636

Run by

Center for International Blood and Marrow Transplant Research

People needed

1812

Starts

2010-01-01

Expected to finish

2016-09-01

Last updated by the study team

2017-06-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Diego — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Florida Center for Cellular Therapy — Orlando, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• Children's Memorial Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana Blood and Marrow Transplantation, LLC — Beech Grove, Indiana, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Iowa Hospitals — Iowa City, Iowa, United States
• University of Kansas Medical Center — Westwood, Kansas, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Barbara Ann Karmanos Cancer Center — Detroit, Michigan, United States
• Helen DeVos Children's Hospital - Spectrum Health — Grand Rapids, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic, Rochester — Rochester, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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