Sickle Cell Disease Transplant Using a Nonmyeloablative Approach: Adding Daratumumab for Patients With Anti-donor Red Cell AntibodY (SUN-RAY)

NCT06358638 Phase 2 RECRUITING

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.

Details

Lead sponsor	Children's National Research Institute
Phase	Phase 2
Status	RECRUITING
Enrolment	12
Start date	2024-04-03
Completion	2054-09

Conditions

• Sickle Cell Disease

Interventions

• Daratumumab
• Alemtuzumab
• Sirolimus
• Total Body Irradiation

Primary outcomes

• 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. — 1-year post-transplant
  Event-free survival rate at 1 year with events including death, graft failure (donor myeloid chimerism \<10% or second HCT), grade II-IV GVHD, and serious pure red blood cell aplasia (persistent reticulocytopenia and need for red blood cell transfusion support after day +100).

Countries

United States