34
Participants
Start Date
September 24, 2015
Primary Completion Date
December 1, 2024
Study Completion Date
March 25, 2025
Rituximab
Rituximab: 375 mg/m\^2 intravenous (IV) day 1 for patients with cluster of differentiation 20 (CD20)-positive disease.
Conditioning chemotherapy
Fludarabine:30 mg/m\^2 per day intravenous (IV) infusion over 30 minutes, daily on days -6, -5, -4, and -3; Cyclophosphamide:1200 mg/m\^2 per day IV infusion over 2 hours on Days 6, -5, -4, -3. Mesna: 1200 mg/m\^2 per day IV infusion, daily on days 6, -5, -4, and -3 Furosemide: 20 mg IV flat dose on days -6, -5, -4, -3; Furosemide: 20 mg IV flat dose on days -6, -5, -4, -3.
TMS
Tacrolimus: 0.02 mg/kg, start day 3. Continue intravenous (IV) or by mouth (PO). Taper will begin at day +60 if no acute graft-versus-host disease (GVHD) then at day +100 and discontinue at day +180 as tolerated. Methotrexate: 5 mg/m\^2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 60, followed by a taper if GVHD does not develop.
FLAG
Fludarabine: 25 mg/m\^2 per day intravenous (IV) over 30 minutes, daily on days 1-5 Cytarabine: 2,000 mg/m\^2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day subcutaneous (SC) beginning 24 hours PRIOR to initiation of chemotherapy.
EPOCH-F
"Fludarabine: 25 mg/m\^2 per day intravenous (IV) infusion over 30 minutes, daily on days 1-4. Etoposide: 50 mg/m\^2 per day continuous IV infusion over 24 hours on days 1-4. Doxorubicin: 10 mg/m\^2/day continuous intravenous (CIV), days 1-4. Vincristine: 0.4 mg/m\^2 per day continuous IV infusion over 24 hours daily on days 1-4.~Cyclophosphamide: 750 mg/m\^2 IV infusion over 30 minutes on day 5. Prednisone: 60 mg/m\^2 per day by mouth (PO) daily on days 1-5. Filgrastim: 5 mcg/kg per day SC or IV."
Hematopoietic stem cell transplant
Hematopoietic stem cell transplant
Palifermin
Escalating doses of palifermin given during transplant phase.
Acetaminophen
Before each infusion of rituximab as indicated.
Diphenhydramine
Before each infusion of rituximab as indicated.
Prednisone
For engraftment syndrome.
Epinephrine
Emergency medication as indicated.
IV Saline
Before each infusion of rituximab as indicated.
ECG
As indicated.
ECHO
As indicated.
MUGA
As indicated.
DEXA
As indicated.
CT chest
As indicated.
PET
As indicated.
MRI
As indicated.
BM aspirate
As indicated.
BM biopsy
As indicated.
Lumbar puncture
As indicated.
National Institutes of Health Clinical Center, Bethesda
National Marrow Donor Program, Minneapolis
National Cancer Institute (NCI)
NIH