Clinical Trial

Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody

Study acronym: SUN-RAY
Recruiting Phase 2
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Summary
This multicenter prospective study seeks to determine if daratumumab given, prior to HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body irradiation, and sirolimus, can prevent pure red blood cell aplasia with an acceptable safety profile in patients with anti-donor red blood cell antibodies, achieving an event-free survival similar to transplanted patients without such antibodies.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-04-09; most recent amendment 2025-09-23.
Trial Details
NCT Number NCT06358638
Lead Sponsor Children's National Research Institute
Collaborators: Alberta Children's Hospital, The Hospital for Sick Children, Levine Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, Nationwide Children's Hospital, Children's Hospital at Montefiore, Doris Duke Charitable Foundation, Janssen Pharmaceuticals
Conditions Sickle Cell Disease
Enrollment 12 participants
Start Date 2024-04-03
Primary Completion 2044-09 (estimated)
Study Completion 2054-09 (estimated)
Updated on ClinicalTrials.gov 2025-09-26