Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody

PHASE2RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 3, 2024

Primary Completion Date

September 30, 2044

Study Completion Date

September 30, 2054

Conditions
Sickle Cell Disease
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

RADIATION

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.

Trial Locations (1)

20010

RECRUITING

Children's National Hospital, Washington D.C.

All Listed Sponsors
collaborator

Alberta Children's Hospital

OTHER

collaborator

The Hospital for Sick Children

OTHER

collaborator

Levine Children's Hospital

OTHER

collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

collaborator

Nationwide Children's Hospital

OTHER

collaborator

Children's Hospital at Montefiore

OTHER

collaborator

Doris Duke Charitable Foundation

OTHER

collaborator

Janssen Pharmaceuticals

INDUSTRY

lead

Children's National Research Institute

OTHER

NCT06358638 - Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody | Biotech Hunter | Biotech Hunter