Donor Stem Cell Transplantation for Congenital Immunodeficiencies

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 19, 2007

Primary Completion Date

November 1, 2019

Study Completion Date

November 1, 2019

Conditions
Inherited Immune Deficiencies
Interventions
DRUG

Campath 1H

Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days

DRUG

Busulfan

Busulfan 5-10 mg/kg total dose given intravenously over 2 days based on patient underlining immune deficiency disorder

DRUG

Horse Anti-human Thymocyte Globulin (h-ATG)

Conditioning with h-ATG 40 mg/kg total dose over 4 days given intravenously

DRUG

Total Body Irradiation (TBI)

TBI 200 - 300 centigray (cGy) in two fractions at day -2 or same day depending on patient underlining immune deficiency disorder

DRUG

Sirolimus or equivalent based on response

post Transplantation immunosuppressants

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00426517 - Donor Stem Cell Transplantation for Congenital Immunodeficiencies | Biotech Hunter | Biotech Hunter