Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

July 31, 2017

Study Completion Date

November 24, 2017

Conditions
Chronic Granulomatous Disease
Interventions
DRUG

Busulfan

"Days -9 through -6~1 mg/kg initially (based on weight)"

BIOLOGICAL

Alemtuzumab

"Day -5 through Day -2~Dose is based on weight:~Less than 15 kg: 3 mg~More than 15 kg to 30 kg: 5 mg~More than 30 kg: 15 mg"

DRUG

Cyclophosphamide

"Days -5 through -2~50 mg/kg"

DRUG

Fludarabine

"Day -5 through Day -2~30 mg/m\^2"

DRUG

Cyclosporine

Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours.

PROCEDURE

Stem Cell Infusion

Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10\^8/kg recipient weight; for cord blood ≥ 3 X 10\^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10\^/kg CD34+ cells.

Trial Locations (1)

77030

Texas Children's Hospital, Houston

All Listed Sponsors
lead

Baylor College of Medicine

OTHER

NCT00578643 - Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease | Biotech Hunter | Biotech Hunter