98
Participants
Start Date
July 3, 2007
Primary Completion Date
October 31, 2016
Study Completion Date
October 31, 2016
Cord Blood Infusion
Cord blood transplantation performed on day 0.
Busulfan
32 mg/m2 by vein as an outpatient before Day -14 or as an inpatient on Day -9, and AUC of 4,000 microMol.min-1 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are \>1 and \< 55 years old. Patients \>55 but \< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).
Fludarabine
"10 mg/m2 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are \>1 and \< 55 years old. Patients \>55 but \< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).~40 mg/m2 by vein on Days -6 to -3 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \> 55 and \< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.~40 mg/m2 by vein on Days -5 to -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are \>1 and \< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3."
Rituximab
375 mg/m2 by vein on Day -9 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \> 55 and \< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.
ATG
"1.25 mg/Kg by vein on Day -4 and 1.75 mg/Kg by vein on Day -3 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \> 55 and \< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.~1.25 mg/kg by vein on Day -3 and 1.75 mg/kg by vein on Day -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are \>1 and \< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3."
Cyclophosphamide
50 mg/kg by vein on Day -6 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \> 55 and \< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.
Clofarabine
30 mg/m2 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are \>1 and \< 55 years old. Patients \>55 but \< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).
Total Body Irradiation (TBI)
200 cGy at 25 cGy/minute delivered on Day -3.
Melphalan
140 mg/m2 by vein on Day -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are \>1 and \< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3.
Tacrolimus
0.03 mg/kg by vein daily starting on D-2, to be changed to oral dosing when tolerated. Tacrolimus is to be tapered around Day +180, if no GVHD is present.
Mycophenolate Mofetil
1 gram by vein twice a day Days -3 through Day 100.
G-CSF
5 mcg/kg/day subcutaneously beginning on day 0, and continuing until the absolute neutrophil count (ANC) is \> 2.5 x 109/L.
University of Texas MD Anderson Cancer Center, Houston
ViaCell
INDUSTRY
National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER