20
Participants
Start Date
September 30, 2011
Primary Completion Date
November 30, 2016
Study Completion Date
June 30, 2018
Fludarabine and Busulfan
"RIC Regimen (Flu/Bu): Fludarabine total dose: 120-180 mg/m\^2, Busulfan: ≤ 8 mg/kg PO or 6.4 mg/kg IV). Recommended regimen:~* Days -6 to -2: Flu (30 mg/m\^2/day, total dose of 150 mg/m\^2)~* Days -5 to -4: Busulfan (4mg/kg/day PO or 3.2 mg/kg IV, 130 mg/m\^2/day, total dose of 8 mg/kg PO or 6.4 mg/kg IV, or 260 mg/m\^2 IV, respectively)~Patients with a creatinine clearance of 40-70 ml/min (measured or calculated) should have a 20 percent dose reduction in Fludarabine dosage.~Busulfan will be dosed according to the recipient's ideal body weight (IBW), unless the patient weighs more than 125 percent of IBW, in which case the drug will be dosed according to the adjusted IBW."
Fludarabine and Melphalan
"RIC Regimen (Flu/Mel): Fludarabine total dose: 120-180 mg/m\^2, Melphalan total dose: less than or equal to 150 mg/m\^2. Recommended regimen:~* Days -5 to -2: Flu (30mg/m\^2/day, total dose of 120 mg/m\^2)~* Day -1: Mel (140mg/m\^2)~Patients with a creatinine clearance of 40-70 ml/min (measured or calculated) should have a 20 percent dose reduction in Fludarabine dosage."
Busulfan and Fludarabine
"MAC Regimen (Bu/Flu): Fludarabine total dose: 120-180mg/m\^2 Busulfan total dose less than or equal to 16mg/kg PO or 12.8 mg/kg IV. Recommended regimen:~* Days -5 to -2: Busulfan (4 mg/kg/day PO with Bu Css 900 plus/equal to 100 ng/mL (or per institutional standard), 3.2 mg/kg/day IV or 130 mg/m\^2/day IV; total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m\^2, respectively)~* Days -5 to -2: Flu (30 mg/m\^2/day, total dose of 120 mg/m\^2)~Patients with a creatinine clearance of 40-70 ml/min (measured or calculated) should have a 20 percent dose reduction in Fludarabine dosage.~Busulfan will be dosed according to the recipient's ideal body weight (IBW), unless the patient weighs more than 125 percent of IBW, in which case the drug will be dosed according to the adjusted IBW."
Cyclophosphamide and Total Body Irradiation
"MAC Regimen (Cy/TBI): Cyclophosphamide total dose: 120 mg/kg, Fractionated TBI total dose: 1200-1420 cGy Recommended regimen:~* Days -7 to -4: TBI (total dose of 1200-1420 cGy)~* Days -3 to -2: Cy (60 mg/kg/day, total dose of 120 mg/kg)~Cyclophosphamide will be dosed according to the recipient's ideal body weight (IBW), unless the patient weighs less than IBW, in which case the drug will be dosed according to the actual body weight."
University of Pennsylvania Cancer Center, Philadelphia
Johns Hopkins, Baltimore
Blood & Marrow Transplant Program at Northside Hospital, Atlanta
H. Lee Moffitt Cancer Center, Tampa
Medical College of Wisconsin, Milwaukee
Mayo Clinic - Rochester, Rochester
University of Texas/MD Anderson CRC, Houston
Texas Transplant Institute, San Antonio
Mayo Clinic - Phoenix, Phoenix
City of Hope National Medical Center, Duarte
University of CA, SF, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Cancer Institute (NCI)
NIH
Blood and Marrow Transplant Clinical Trials Network
NETWORK
National Marrow Donor Program
OTHER
Medical College of Wisconsin
OTHER