Hematopoietic Stem Cell Transplant for High Risk Hemoglobinopathies (NCT02179359) | Clinical Trial Compass
TerminatedNot Applicable
Hematopoietic Stem Cell Transplant for High Risk Hemoglobinopathies
Stopped: Replaced by another study
United States38 participantsStarted 2014-09-02
Plain-language summary
This is a study to collect the outcomes of stem cell transplantation for patients with hematologic diseases other than cancer.
Who can participate
Age range
55 Years
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:
* Diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated
* Acceptable stem cell source identified
* Performance status of ≥ 70% (Karnofsky),or ≥ 70 (Lansky play score)
* Creatinine \<2.0 mg/dl for adults or glomerular filtration rate \> 50 ml/min for children
* Bilirubin, Aspartate Aminotransferase, Alkaline phosphatase \<5 times the upper limit of institutional normal
* Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 40%
Exclusion Criteria:
* active, uncontrolled infection
* pregnant or breastfeeding
* HIV positive
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.
1This trial was terminated before completing — do you know why it was stopped, and does that affect whether its approach to stem cell transplant is still considered safe or relevant for my condition?
2Since the main thing this trial was measuring was graft failure — meaning the transplanted cells not taking hold — how does the current evidence on graft failure risk apply to my specific diagnosis, whether that's sickle cell disease or another disorder on this list?
3Given that this trial covered a wide range of conditions from sickle cell disease to Glanzmann Thrombasthenia, is a stem cell transplant even the recommended path for my particular diagnosis right now, or are there other standard treatments I should try first?
4Because this trial has been terminated, are there other active clinical trials studying stem cell transplants for my condition that might have more up-to-date safety and outcome data I could consider instead?
5Stem cell transplants carry serious risks like graft-versus-host disease and infection — given that this trial didn't fully complete and we may have limited data on outcomes, how would you weigh those risks against the potential benefits for someone in my situation?
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.
What they're measuring
1
incidence of graft failure
Timeframe: 42 days
Trial details
NCT IDNCT02179359
SponsorMasonic Cancer Center, University of Minnesota