400
Participants
Start Date
July 9, 2019
Primary Completion Date
November 25, 2025
Study Completion Date
October 26, 2026
Busulfan
Busulfan should be administered intravenously via a central venous catheter as a three-hour infusion every 24 hours.
Fludarabine
Fludarabine will be infused by IV over 60 minutes.
Cyclophosphamide
IV cyclophosphamide will be administered over 2 hours. Slower rates of infusion may be used to decrease side effects. A fluid intake of greater than 2 L/day is recommended during and for 1 to 2 days after cyclophosphamide administration.
Mycophenolate Mofetil
Any oral formulation should be taken on an empty stomach, 1 hour before or at least 2 hours after meals. Oral formulations should not be administered simultaneously with antacids. Avoid inhalation or direct contact with skin or mucous membranes of dry powder contained in capsules or suspension. IV solutions should be administered over at least two hours through either a peripheral or central vein and should not be administered by rapid or bolus injection.
Sirolimus
Oral tablets should be administered approximately 4 hours after cyclosporine administration. Sirolimus is administered orally, once daily, without food. Patients unable to tolerate tablets may take the oral solution formulation.
RECRUITING
National Institutes of Health Clinical Center, Bethesda
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
National Cancer Institute (NCI)
NIH