Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) non-Hodgkin's lymphomas: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed. ABBV-101 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-101 and a dose expansion phase to determine the change in disease activity in participants with first line treatment (1L), second line or later of treatment (2L)+ CLL/SLL or third line or later of treatment (3L) non-GCB DLBCL. Approximately 340 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating oral doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 88 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101, as part of the approximately 88 month study duration . 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, and side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
340
Oral:Tablet
Arizona Oncology Associates, PC-HOPE /ID# 252351
Tempe, Arizona, United States
RECRUITINGUC Irvine Medical Center /ID# 263020
Orange, California, United States
RECRUITINGStanford University /ID# 249683
Palo Alto, California, United States
RECRUITINGRocky Mountain Cancer Centers - Lone Tree /ID# 252237
Lone Tree, Colorado, United States
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 Approximately 88 Months
Change in Laboratory Parameters
Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Time frame: Up to Approximately Two Years
Change in Vital Signs
Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Time frame: Up to Approximately Two Years
Change in Electrocardiogram (ECG)
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Time frame: Up to Approximately Two Years
Maximum Observed Serum Concentration (Cmax) of ABBV-101
Maximum observed serum concentration of ABBV-101.
Time frame: Up to Approximately One Year
Time to Cmax (Tmax) of ABBV-101
Time to Cmax of ABBV-101.
Time frame: Up to Approximately One Year
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-101
Area under the serum concentration versus time curve (AUC) of ABBV-101.
Time frame: Up to Approximately One Year
Number of Participants with Response of Partial Response (PR) or Better Response (Overall Response) per Disease-Specific Criteria
Number of participants with response of PR or better response (overall response) per disease-specific criteria.
Time frame: Up to Approximately Two Years
Duration of Response (DOR)
DOR is defined for participants achieving PR or better 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 Approximately Two Years
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Northwestern University Feinberg School of Medicine /ID# 249347
Chicago, Illinois, United States
RECRUITINGBeth Israel Deaconess Medical Center /ID# 249302
Boston, Massachusetts, United States
RECRUITINGRutgers Cancer Institute of New Jersey /ID# 249323
New Brunswick, New Jersey, United States
RECRUITINGNew York Oncology Hematology - Albany Cancer Center /ID# 252240
Albany, New York, United States
COMPLETEDNorthwell Health - Monter Cancer Center /ID# 250422
Lake Success, New York, United States
RECRUITINGUniversity of Rochester Medical Center /ID# 249324
Rochester, New York, United States
RECRUITING...and 41 more locations