5
Participants
Start Date
July 30, 2015
Primary Completion Date
October 6, 2020
Study Completion Date
October 6, 2020
Rituximab
375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine
40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide
50 mg/kg by vein on Day -8.
Total Body Radiation
2 Gy delivered on Day -4.
Fucosylated Regulatory T Cells
"Phase I: Participants treated at cell dose level 1: 1 x 10\^6/kg Fucosylated T-reg cells on Day -1.~Phase II: Participants treated at cell dose level 2: 1 x 10\^7/kg Fucosylated T-reg cells on Day -1."
Cord Blood Infusions
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate mofetil
15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus
12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
Bone Marrow Aspiration
Bone marrow aspiration performed at 1, 3, 6, and 12 months after transplant to check status of disease.
G-CSF
5 mcg/kg/day subcutaneously beginning on D+0, and continuing until absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.
Non-Fucosylated Regulatory T Cells
"Phase I: Participants treated at cell dose level 1: 1 x 10\^7/kg Non-Fucosylated T-reg cells on Day -1.~Phase II: Participants treated at cell dose level 2: 1 x 10\^7/kg Non-Fucosylated T-reg cells on Day -1."
University of Texas MD Anderson Cancer Center, Houston
National Cancer Institute (NCI)
NIH
Cancer Prevention Research Institute of Texas
OTHER
M.D. Anderson Cancer Center
OTHER