drugset / Trial / NCT06358638
Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody
Phase 2
Recruiting
12 enrolled
Children's National Research Institute
Alberta Children's Hospital · collabAnn & Robert H Lurie Children's Hospital of Chicago · collabChildren's Hospital at Montefiore · collabDoris Duke Charitable Foundation · collabJanssen Pharmaceuticals · collabLevine Children's Hospital · collabNationwide Children's Hospital · collabThe Hospital for Sick Children · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-04-03
- Primary completion
- 2044-09
- Completion
- 2054-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | — | Intravenous |
| Background | Alemtuzumab | Monoclonal antibody | — | Subcutaneous |
| Background | Sirolimus | Small molecule | — | — |