12
Participants
Start Date
April 3, 2024
Primary Completion Date
September 30, 2044
Study Completion Date
September 30, 2054
Daratumumab
Daratumumab is a cytotoxic monoclonal antibody (IgG1k) to CD38 and is commercially approved to treat multiple myeloma. CD38 is expressed on several types of blood cells including B-cells, antibody-secreting plasma blasts and plasma cells. As a result, it has been used to treat antibody-mediated diseases, including children with antibody-mediated cytopenias post-HCT.
Alemtuzumab
Alemtuzumab is a humanized monoclonal antibody specific to lymphocyte antigens. It is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) that is directed against the 21-28 kD cell surface glycoprotein, CD52.
Sirolimus
Sirolimus is an mTOR inhibitor immunosuppressant used to prevent organ transplant rejections as well as treat lymphangioleiomyomatosis and adults with perivascular epithelioid cell tumors.
Total Body Irradiation
Total body irradiation is a form of radiotherapy used primarily as part of the preparative regimen for haematopoietic stem cell transplantation. The radiation is given in a low dose so that normal tissues can repair themselves.
RECRUITING
Children's National Hospital, Washington D.C.
Lead Sponsor
Collaborators (1)
Alberta Children's Hospital
OTHER
The Hospital for Sick Children
OTHER
Levine Children's Hospital
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Nationwide Children's Hospital
OTHER
Children's Hospital at Montefiore
OTHER
Doris Duke Charitable Foundation
OTHER
Janssen Pharmaceuticals
INDUSTRY
Children's National Research Institute
OTHER