Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodY - Trial NCT06358638
Access comprehensive clinical trial information for NCT06358638 through Pure Global AI's free database. This Phase 2 trial is sponsored by Children's National Research Institute and is currently Recruiting. The study focuses on Sickle Cell Disease. Target enrollment is 12 participants.
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Study Focus
Sponsor & Location
Children's National Research Institute
Timeline & Enrollment
Phase 2
Apr 01, 2024
Sep 01, 2054
Primary Outcome
To determine the event-free survival of children and adolescents with SCD undergoing nonmyeloablative HCT who received 4 doses of pre-HCT daratumumab for donor-directed red blood cell antibodies.
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06358638
Non-Device Trial