2024-11-21
notable
Recruiting→Active, Not Recruiting Study Identification, Study Status, Oversight, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2027-01→2026-11
Completion date2027-01→2026-11
Enrollment targetestimated 58→confirmed 43
Study sitesdetails revised at 15 of 15 sites
2023-11-07
minor
Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
Eligibility criteria+112 characters
[...] vaso-occlusive pain episodes (defined as above, lifetime).
NoPatients clinical manifestations ofwith HbSS and HbSβ°thalassemia who have no clinical complications of their sickle cell disease and do not meet the criteria for less severe or severe disease.
Participant's parent or legal guardian must sign a written [...]
Secondary endpointsdetails revised at 11 of 15 entries
2021-07-13
minor
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility v2
Eligibility criteria+183 characters
Inclusion Criteria:
Patients must be at least 2 years and less than 1013 years old and have a sickle hemoglobinopathy.
Patient must have an HLA identical sibling donor who is less than 1013 years old.
Sibling donors must not have any form of SCD.
It [...] vaso-occlusive pain episodes (defined as above, lifetime).
No clinical manifestations of HbSS and HbSβ°thalassemia
Participant's parent or legal guardian must sign a written i [...] ding treatment options for SCD by a pediatric hematologist.
Co-enrollment on STAR Project Sickle Cure (PSC) study is required for sites that are activated and participating in [...] [...]
Study description+41 characters
[...] inally, with the recognition that most children, even those withwho have asymptomatic to relatively mild courses, will develop debilitating morbidit [...] rmed for a growing number of less severely affected children, as well as children without disease manifestation.
This trial is designed to prospectively assess HSCT under [...] nditions.
Eligibility will be limited to children less than 1013 years of age who have an HLA MSD who is also less than 10 years.
A RIC regimen - fludarabine, alemtuzumab and melphalan (FA [...] ly, SCD severity criteria will be broadened to include less severalseverely affected children [...] [...]