protocolSection identificationModule nctId: NCT06358638, orgStudyIdInfo id: STUDY00000859, briefTitle: Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodY, acronym: SUN-RAY, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2044-09, completionDateStruct date: 2054-09, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Children's National Research Institute, class: OTHER, collaborators name: Alberta Children's Hospital, collaborators name: The Hospital for Sick Children, collaborators name: Levine Children's Hospital, collaborators name: Ann & Robert H Lurie Children's Hospital of Chicago, collaborators name: Nationwide Children's Hospital, collaborators name: Children's Hospital at Montefiore, collaborators name: Doris Duke Charitable Foundation, collaborators name: Janssen Pharmaceuticals, descriptionModule briefSummary: 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., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Sickle cell patients, who have matched sibling donors with anti-donor RBC antibodies., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Daratumumab, interventions name: Alemtuzumab, interventions name: Sirolimus, interventions name: Total Body Irradiation, outcomesModule primaryOutcomes measure: 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., secondaryOutcomes measure: To evaluate changes in antibodies to red blood cell antigens pre and post exposure to daratumumab and HCT., secondaryOutcomes measure: To characterize the safety of adding pre-HCT daratumumab to the conditioning regimen, as defined by adverse events grade 3 or greater., otherOutcomes measure: To compare alemtuzumab levels, in mcg/mL, post-HCT among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study., otherOutcomes measure: To compare immune reconstitution among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study., otherOutcomes measure: To compare donor chimerism (lymphoid vs myeloid) post-HCT among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study., eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Children's National Hospital, status: RECRUITING, city: Washington, state: District of Columbia, zip: 20010, country: United States, contacts name: Maryanne Odinakachukwu, role: CONTACT, phone: 202-476-2957, email: modinakach@childrensnational.org, contacts name: Robert Nickel, role: PRINCIPAL_INVESTIGATOR, contacts name: David Jacobsohn, role: SUB_INVESTIGATOR, contacts name: Anant Vatsayan, role: SUB_INVESTIGATOR, contacts name: Blachy Dávila-Saldaña, role: SUB_INVESTIGATOR, contacts name: Evelio Perez-Albuerne, role: SUB_INVESTIGATOR, contacts name: Catherine Bollard, role: SUB_INVESTIGATOR, geoPoint lat: 38.89511, lon: -77.03637, hasResults: False