Histological confirmation of relapsed/refractory diffuse large B-cell lymphoma after prior rituximab and anthracycline-containing systemic treatment regimen such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), R-EPOCH (rituximab, etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride), R-HyperCVAD (rituximab, cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone) etc. 
Subjects must have received no more than 2 prior systemic therapies for lymphoma. Prior therapy with systemic rituximab monotherapy or conventional chemotherapy (i.e. bendamustine, CVP (Cyclophosphamide, Vincristine Sulfate, Prednisone) or other) ± rituximab for indolent non-Hodgkin's lymphoma (NHL) ± maintenance/extended-use rituximab will count as 1 line of systemic therapy. 
Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2 
Subjects must have normal organ and marrow function as defined below: 
Hemoglobin ≥ 8.0 g/dl 
Absolute neutrophil count ≥ 1,000/mcL 
Platelet count ≥ 75,000/mcL 
Total bilirubin ≤ 1.5 X the upper limit of normal (ULN) unless a known history of impaired bilirubin conjugation such as Gilbert's, for whom the maximum will be 2.5 ULN. 
Aspartate transaminase (AST) (SGOT) ≤ 2.5 X institutional ULN 
Alanine transaminase (ALT) (SGPT) ≤ 2.5 X institutional ULN 
International normalized ratio (INR) > 1.5 ×ULN 
Patients must have a calculated serum creatinine clearance > 50 mL/min using Cockcroft-Gault calculation or based on 24-hour urine collection performed within 7 days prior to treatment. 
Specific guidelines will be followed regarding inclusion of relapsed/refractory DLBCL based on Hepatitis B serological testing as follow: 
HBsAg negative, HBcAb negative, HBsAb positive patients are eligible. 
Patients who test positive for HBsAg are ineligible 
Patients with HBsAg negative, but HBcAb positive (regardless of HBsAb status) should have a HBV DNA testing performed and protocol eligibility determined as follow: 
If HBV DNA is positive, the subject is ineligible. 
If HBV DNA is negative, the subject may be included but must undergo HBV DNA PCR testing monthly x 3 months beginning from the start of treatment 
Subjects must have the ability to understand and the willingness to sign a written informed consent document. 
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 30 days after the last dose of venetoclax or 18 months after the last dose of rituximab, whichever is longer. 
A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). 
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: 
With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of rituximab. Men must refrain from donating sperm during this same period. 
With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of rituximab to avoid exposing the embryo. 

NCT03064867_inc_T1
Procedure
Histological
NCT03064867_inc_T2
Value
confirmation
NCT03064867_inc_T3
Condition
B-cell lymphoma
NCT03064867_inc_T4
Qualifier
large
NCT03064867_inc_T5
Qualifier
diffuse
NCT03064867_inc_T7
Procedure
rituximab and anthracycline-containing systemic treatment regimen
NCT03064867_inc_T8
Drug
R-CHOP
NCT03064867_inc_T9
Drug
rituximab
NCT03064867_inc_T10
Drug
cyclophosphamide
NCT03064867_inc_T11
Drug
doxorubicin
NCT03064867_inc_T12
Drug
vincristine
NCT03064867_inc_T13
Drug
prednisone
NCT03064867_inc_T14
Scope
rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
NCT03064867_inc_T15
Drug
R-EPOCH
NCT03064867_inc_T16
Drug
rituximab
NCT03064867_inc_T17
Drug
etoposide phosphate
NCT03064867_inc_T18
Drug
prednisone
NCT03064867_inc_T19
Drug
vincristine sulfate
NCT03064867_inc_T20
Drug
cyclophosphamide
NCT03064867_inc_T21
Drug
doxorubicin hydrochloride
NCT03064867_inc_T22
Scope
rituximab, etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride
NCT03064867_inc_T23
Drug
R-HyperCVAD
NCT03064867_inc_T24
Drug
rituximab
NCT03064867_inc_T25
Drug
cyclophosphamide
NCT03064867_inc_T26
Drug
vincristine sulfate
NCT03064867_inc_T27
Drug
doxorubicin hydrochloride
NCT03064867_inc_T28
Drug
dexamethasone
NCT03064867_inc_T29
Scope
rituximab, cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone
NCT03064867_inc_T6
Drug
rituximab
NCT03064867_inc_T30
Drug
anthracycline
NCT03064867_inc_T31
Scope
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), R-EPOCH (rituximab, etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride), R-HyperCVAD (rituximab, cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone) etc
NCT03064867_inc_T32
Temporal
after
NCT03064867_inc_T33
Reference_point
prior rituximab and anthracycline-containing systemic treatment regimen
NCT03064867_inc_T34
Multiplier
no more than 2
NCT03064867_inc_T35
Temporal
prior
NCT03064867_inc_T36
Procedure
systemic therapies for lymphoma
NCT03064867_inc_T37
Drug
rituximab
NCT03064867_inc_T38
Procedure
systemic monotherapy
NCT03064867_inc_T39
Temporal
Prior
NCT03064867_inc_T40
Procedure
conventional chemotherapy
NCT03064867_inc_T41
Drug
bendamustine
NCT03064867_inc_T42
Drug
CVP
NCT03064867_inc_T43
Drug
Cyclophosphamide
NCT03064867_inc_T44
Drug
Vincristine Sulfate
NCT03064867_inc_T45
Drug
Prednisone
NCT03064867_inc_T46
Scope
Cyclophosphamide, Vincristine Sulfate, Prednisone
NCT03064867_inc_T47
Drug
rituximab
NCT03064867_inc_T48
Condition
non-Hodgkin's lymphoma (NHL)
NCT03064867_inc_T49
Qualifier
indolent
NCT03064867_inc_T50
Drug
rituximab
NCT03064867_inc_T51
Scope
bendamustine, CVP (Cyclophosphamide, Vincristine Sulfate, Prednisone) or other
NCT03064867_inc_T52
Qualifier
maintenance
NCT03064867_inc_T53
Qualifier
extended-use
NCT03064867_inc_T54
Scope
maintenance/extended-use
NCT03064867_inc_T55
Measurement
Eastern Cooperative Oncology Group (ECOG) Performance status
NCT03064867_inc_T56
Value
≤ 2
NCT03064867_inc_T57
Condition
normal organ function
NCT03064867_inc_T58
Condition
normal marrow function
NCT03064867_inc_T59
Scope
Subjects must have normal organ and marrow function as defined below:
NCT03064867_inc_T60
Measurement
Hemoglobin
NCT03064867_inc_T61
Value
≥ 8.0 g/dl
NCT03064867_inc_T62
Measurement
Absolute neutrophil count
NCT03064867_inc_T63
Value
≥ 1,000/mcL
NCT03064867_inc_T64
Measurement
Platelet count
NCT03064867_inc_T65
Value
≥ 75,000/mcL
NCT03064867_inc_T66
Measurement
Total bilirubin
NCT03064867_inc_T67
Value
≤ 1.5 X the upper limit of normal (ULN)
NCT03064867_inc_T68
Condition
impaired bilirubin conjugation
NCT03064867_inc_T69
Condition
Gilbert's
NCT03064867_inc_T70
Value
maximum 2.5 ULN
NCT03064867_inc_T71
Scope
≤ 1.5 X the upper limit of normal (ULN) unless a known history of impaired bilirubin conjugation such as Gilbert's, for whom the maximum will be 2.5 ULN
NCT03064867_inc_T72
Measurement
Aspartate transaminase (AST) (SGOT)
NCT03064867_inc_T73
Value
≤ 2.5 X institutional ULN
NCT03064867_inc_T74
Measurement
Alanine transaminase (ALT) (SGPT)
NCT03064867_inc_T75
Value
≤ 2.5 X institutional ULN
NCT03064867_inc_T76
Measurement
International normalized ratio (INR)
NCT03064867_inc_T77
Value
> 1.5 ×ULN
NCT03064867_inc_T78
Measurement
serum creatinine clearance
NCT03064867_inc_T79
Value
> 50 mL/min
NCT03064867_inc_T80
Qualifier
Cockcroft-Gault calculation
NCT03064867_inc_T81
Qualifier
24-hour urine collection
NCT03064867_inc_T82
Temporal
within 7 days prior
NCT03064867_inc_T83
Reference_point
treatment
NCT03064867_inc_T84
Scope
Cockcroft-Gault calculation or based on 24-hour urine collection
NCT03064867_inc_T86
Measurement
HBsAg
NCT03064867_inc_T87
Value
negative
NCT03064867_inc_T88
Measurement
HBcAb
NCT03064867_inc_T89
Value
negative
NCT03064867_inc_T90
Measurement
HBsAb
NCT03064867_inc_T91
Value
positive
NCT03064867_inc_T92
Measurement
HBsAg
NCT03064867_inc_T93
Value
positive
NCT03064867_inc_T95
Measurement
HBsAg
NCT03064867_inc_T96
Value
negative
NCT03064867_inc_T97
Measurement
HBcAb
NCT03064867_inc_T98
Value
positive
NCT03064867_inc_T99
Procedure
HBV DNA testing
NCT03064867_inc_T101
Measurement
HBV DNA
NCT03064867_inc_T102
Value
positive
NCT03064867_inc_T104
Measurement
HBV DNA
NCT03064867_inc_T105
Value
negative