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, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-291 in adult participants in relapsed or refractory (R/R) NHL, including but not limited to diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Adverse events will be assessed. ABBV-291 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-291 and a dose expansion/optimization phase to determine the change in disease activity in participants with R/R NHL. Approximately 165 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 Intravenously (IV) infused doses of ABBV-291, until the MAD/MTD is determined. In the dose expansion/optimization phase of the study participants receive IV infused ABBV-291, as part of the approximately 74 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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
Intravenous Infusion
Carolina BioOncology Institute /ID# 265259
Huntersville, North Carolina, United States
COMPLETEDWillamette Valley Cancer Institute and Research Center /ID# 270945
Eugene, Oregon, United States
RECRUITINGTexas Oncology - Central/South Texas /ID# 270946
Austin, Texas, United States
RECRUITINGSTART Mountain Region /ID# 267592
West Valley City, Utah, United States
COMPLETEDVirginia Cancer Specialists - Fairfax /ID# 265082
Fairfax, Virginia, United States
COMPLETEDSt Vincent's Hospital Melbourne /ID# 261664
Fitzroy Melbourne, Victoria, Australia
RECRUITINGSir Charles Gairdner Hospital /ID# 268579
Nedlands, Western Australia, Australia
RECRUITINGHadassah Medical Center-Hebrew University /ID# 261658
Jerusalem, Jerusalem, Israel
RECRUITINGTel Aviv Sourasky Medical Center /ID# 261659
Tel Aviv, Tel Aviv, Israel
RECRUITINGAichi Cancer Center /ID# 267471
Nagoya, Aichi-ken, Japan
RECRUITING...and 4 more locations
Percentage of Participants with Adverse Events (AE)s
An 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 74 Months
Percentage of Participants with Dose Limiting Toxicities (DLT)s
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Time frame: Up to 74 Months
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, and Hematology)
Percentage of participants with clinically significant laboratory values (chemistry, and hematology).
Time frame: Up to 74 Months
Percentage of Participants with Clinically Significant Vital Sign Measurements
Vital sign are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature.
Time frame: Up to 74 Months
Percentage of Participants with Clinically Significant Electrocardiogram (ECG) Findings
Percentage of participants with clinically significant ECG findings.
Time frame: Up to 74 Months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) or better per disease-specific response criteria (e.g., Lugano classification).
Time frame: Up to 74 Months
Duration of Response (DOR) as Assessed by Investigator
DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to disease-specific response criteria to disease progression or death of any cause, whichever occurs earlier.
Time frame: Up to 74 Months
Progression-Free Survival (PFS) as Assessed by Investigator
PFS is defined as time from first study treatment to a documented disease progression according to disease-specific response criteria, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Time frame: Up to 74 Months
Time to response (TTR)
TTR is defined as time from first study treatment to the initial response of PR (or better) per investigator review according to disease-specific response criteria.
Time frame: Up to 74 Months
Area Under the Curve (AUC) of ABBV-291
AUC is defined as the area under the plasma/serum concentration-time curve of ABBV-291.
Time frame: Up to 12 Months
Maximum Observed Plasma/Serum Concentration (Cmax) of ABBV-291
Cmax is defined as maximum observed plasma/serum concentration of ABBV-291.
Time frame: Up to 12 Months
Time to Cmax (Tmax) of ABBV-291
Tmax is defined as time to Cmax of ABBV-291.
Time frame: Up to 12 Months
Half-Life (t1/2) of ABBV-291
t1/2 is defined as the half-life of ABBV-291.
Time frame: Up to 12 Months
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