Stem Cell Related Donor Safety Study (NCT00948636) | Clinical Trial Compass
CompletedNot Applicable
Stem Cell Related Donor Safety Study
United States1,812 participantsStarted 2010-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00948636
SponsorCenter for International Blood and Marrow Transplant Research