14
Participants
Start Date
April 19, 2022
Primary Completion Date
June 1, 2024
Study Completion Date
June 1, 2029
Obinutuzumab
Obinutuzumab 1000 mg IV (intravenous) days 1 and 2 for a maximum of 6 cycles every 21 days (each cycle is 21 days)
Prednisone
Prednisone 100 mg PO (by mouth) daily days 1-7 for a maximum of 6 cycles every 21 days (each cycle is 21 days)
Lenalidomide
Lenalidomide 10 or 15 mg PO (by mouth) on days 1-14 for 1 cycle (21 days); followed by Lenalidomide 10 or 15 mg PO daily days 1-14 for a maximum of 6 cycles every 21 days (each cycle is 21 days)
Venetoclax
Venetoclax 800 mg PO (by mouth) on days 1-14 for a maximum of 6 cycles every 21 days (each cycle is 21 days)
Ibrutinib
Ibrutinib 560 mg PO (by mouth) daily days 1-14 for a maximum of 6 cycles every 21 days (each cycle is 21 days)
Acetaminophen
650 mg by mouth (PO) daily on days 1 and 2 approximately 30-60 minutes prior to Obinutuzumab infusion.
Diphenhydramine
50mg by mouth (PO) daily on days 1 and 2 approximately 30-60 minutes prior to Obinutuzumab infusion.
Peg-filgrastim
6 mg subcutaneous once on day 8 only.
CT Scan (chest, abdomen, and pelvis)
To assess sites of disease.
MRI
If clinically indicated.
18f-FDG-PET
If clinically indicated.
PET
If clinically indicated.
Lumbar puncture/Ommaya tap
If clinically indicated.
Bone marrow aspiration/biopsy
If clinically indicated.
EKG
To determine eligibility.
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH