Stem Cell Related Donor Safety Study

Completed

• Conditions: Related Hematopoietic Stem Cell Donors

• Registration Number: NCT00948636
• Lead Sponsor: Center for International Blood and Marrow Transplant Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-28
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Study Start: 2010-01
• Primary Completion: 2015-08
• Status Verified: 2016-07
• Study Completion: 2016-09
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1812

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (52)

Banner Good Samaritan Medical Center; 🇺🇸 Phoenix, Arizona, United States

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; 🇺🇸 Saint 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

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