Allogeneic Transplant in HIV Patients (BMT CTN 0903)

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

November 30, 2016

Study Completion Date

June 30, 2018

Conditions
LeukemiaLymphomaHIV
Interventions
DRUG

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."

DRUG

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."

DRUG

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."

DRUG

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."

Trial Locations (11)

19104

University of Pennsylvania Cancer Center, Philadelphia

21231

Johns Hopkins, Baltimore

30342

Blood & Marrow Transplant Program at Northside Hospital, Atlanta

33624

H. Lee Moffitt Cancer Center, Tampa

53211

Medical College of Wisconsin, Milwaukee

55905

Mayo Clinic - Rochester, Rochester

77030

University of Texas/MD Anderson CRC, Houston

78229

Texas Transplant Institute, San Antonio

85054

Mayo Clinic - Phoenix, Phoenix

91010

City of Hope National Medical Center, Duarte

94143-0324

University of CA, SF, San Francisco

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

collaborator

National Marrow Donor Program

OTHER

lead

Medical College of Wisconsin

OTHER

NCT01410344 - Allogeneic Transplant in HIV Patients (BMT CTN 0903) | Biotech Hunter | Biotech Hunter