B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), or R/R CLL. Adverse events will be assessed. ABBV-319 is an investigational drug being developed for the treatment of R/R DLBCL, R/R FL, or R/R CLL. This study will include a dose escalation phase to determine the doses of ABBV-319 that will be used in the next phase and a dose expansion phase to determine the change in disease activity in participants with R/R DLBCL, R/R FL, and R/R CLL. Approximately 154 adult participants with R/R B cell lymphomas including R/R DLBCL, R/R FL, and R/R CLL will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the Phase 2 dose is determined. In the dose expansion phase of the study participants receive intravenously infused ABBV-319 in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Intravenous (IV); Infusion
University of Arizona Cancer Center - Tucson /ID# 247752
Tucson, Arizona, United States
RECRUITINGSylvester Comprehensive Cancer Center - University of Miami /ID# 247232
Miami, Florida, United States
COMPLETEDAllina Health System /ID# 251782
Minneapolis, Minnesota, United States
RECRUITINGUniversity of Nebraska Medical Center /ID# 246715
Omaha, Nebraska, United States
RECRUITINGMemorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
New York, New York, United States
RECRUITINGNovant Health Presbyterian Medical Center /ID# 246719
Charlotte, North Carolina, United States
RECRUITINGBaylor Sammons Cancer Center /ID# 247715
Dallas, Texas, United States
RECRUITINGUniversity of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
San Antonio, Texas, United States
RECRUITINGConcord Repatriation General Hospital /ID# 249240
Concord, New South Wales, Australia
RECRUITINGSt Vincent's Hospital Melbourne /ID# 247624
Fitzroy Melbourne, Victoria, Australia
RECRUITING...and 10 more locations
Number of Dose-Limiting Toxicities (DLT)
A DLT is defined as any adverse event (AE) for which a clear alternative cause cannot be established (eg, attributed to the disease under study, another disease, or to a concomitant medication by the study investigators or medical monitor).
Time frame: Day 42
Number of Participants with Adverse Events (AE)
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 30 Months
Maximum Observed Serum Concentration (Cmax) of ABBV-319
Maximum observed serum concentration of ABBV-319.
Time frame: Up to 6 Months
Time to Cmax (Tmax) of ABBV-319
Time to Cmax of ABBV-319.
Time frame: Up to 6 Months
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
Terminal phase elimination half-life of ABBV-319.
Time frame: Up to 6 Months
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319
Area under the serum concentration versus time curve (AUC) of ABBV-319.
Time frame: Up to 6 Months
Antidrug Antibody (ADA)
Incidence and concentration of anti-drug antibodies.
Time frame: Up to 6 Months
Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria
Number of participants with response of PR or better per disease-specific criteria.
Time frame: Up to 6 Months
Duration of Response (DOR)
DOR is defined for participants achieving a complete response (CR)/PR as the time from the initial response per investigator review to disease progression or death of any cause, whichever occurs earlier.
Time frame: Up to 6 Months
Time to Response
Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.
Time frame: Up to 6 Months
Progression Free Survival (PFS) Time
PFS is defined as time from first study treatment to a documented disease progression as determined by the investigator, or death due to any cause, whichever occurs earlier.
Time frame: Up to 30 Months
Overall survival (OS) Time
OS is defined as time from first study treatment to death due to any cause.
Time frame: Up to 30 Months
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