Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Percentage of Participants With Adverse Events (AEs) |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. |
Up to approximately 25 months. |
|
Primary |
Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of ABBV-623 |
The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that ABBV-623 achieves in the blood after administration in a dosing interval. |
Up to approximately 96 weeks |
|
Primary |
Dose Escalation: Area Under the Plasma Concentration- Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration of ABBV-623 |
The area under the plasma concentration-time curve (AUC; measured in h*ng/mL/mg) is a method of measurement of the total exposure of ABBV-623 in blood plasma. |
Up to approximately 96 weeks |
|
Primary |
Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of ABBV-992 |
The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that ABBV-992 achieves in the blood after administration in a dosing interval. |
Up to approximately 96 weeks. |
|
Primary |
Dose Escalation: Area Under the Plasma Concentration- Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration of ABBV-992 |
The area under the plasma concentration-time curve (AUC; measured in h*ng/mL/mg) is a method of measurement of the total exposure of ABBV-992 in blood plasma. |
Up to approximately 96 weeks |
|
Primary |
Combination Dose Expansion: Overall Response Rate (ORR) (PR or Better by IWCLL Criteria) in Participants With R/R CLL/SLL |
ORR is the proportion of R/R CLL/SLL participants achieving a response of PR or better per IWCLL without the use of new anti-cancer therapy. |
Up to approximately 2 years |
|
Secondary |
Dose Escalation in Participants With R/R B-cell Malignancies: Percentage of Participants Achieving a Response of Partial Response (PR) or Better per Disease-Specific Response Criteria (e.g., IWCLL, Lugano, IWWM) |
Partial response (PR) as per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) , Lugano, International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria in protocol. |
Up to approximately 2 years |
|
Secondary |
Dose Escalation in Participants With R/R B-cell Malignancies: Duration of Response (DOR) for Participants With a Response of PR or Better |
Duration of Response (DOR) is defined as the time from the date of the participant's documented first response of PR or better to the date of documented disease progression or death due to the disease, whichever occurs first. |
Up to approximately 2 years |
|
Secondary |
Dose Escalation in Participants With R/R B-cell Malignancies: Time to Response (TTR) |
Time to response, defined as the length of time from the date of first dose of study drug to the date of first response of PR or better per disease-specific response criteria. |
Up to approximately 2 years |
|
Secondary |
Monotherapy Dose Expansion in Participants With R/R B-cell Malignancies: Achievement of a Response of PR or Better |
Partial response (PR) as per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) , Lugano, International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria in protocol. |
Up to approximately 2 years |
|
Secondary |
Monotherapy Dose Expansion in Participants With R/R B-cell Malignancies: Duration of Response (DOR) for Participants With a Response of PR or Better |
Duration of Response (DOR) is defined as the time from the date of the participant's documented first response of PR or better to the date of documented disease progression or death due to the disease, whichever occurs first. |
Up to approximately 2 years |
|
Secondary |
Monotherapy Dose Expansion in Participants With R/R B-cell Malignancies: Time to Response (TTR) |
Time to response, defined as the length of time from the date of first dose of study drug to the date of first response of PR or better per disease-specific response criteria. |
Up to approximately 2 years |
|
Secondary |
Combination Dose Expansion in Participants With CLL/SLL: Achievement of Bone Marrow Undetectable Minimal Residual Disease (uMRD) |
Undetectable minimal residual disease (uMRD) is described as less than one myeloma cell per million bone marrow cells. |
Up to approximately 6 months |
|
Secondary |
Combination Dose Expansion in Participants With CLL/SLL: Achievement of Bone Marrow Undetectable Minimal Residual Disease (uMRD) |
Undetectable minimal residual disease (uMRD) is described as less than one myeloma cell per million bone marrow cells. |
Up to approximately 1 Year |
|
Secondary |
Combination Dose Expansion in Participants With CLL/SLL: Percentage of Participants With Achievement of Peripheral Blood uMRD |
Peripheral blood Undetectable minimal residual disease (uMRD) is described as less than one CLL cell per 10,000 leukocytes (or below 10^-4) or as specified in the protocol. |
Up to approximately 96 weeks |
|
Secondary |
Combination Dose Expansion in Participants With CLL/SLL: Duration of Response for Participants With a Response of PR or Better |
Duration of response is defined as the time from the initial objective response to disease progression or death, whichever occurs first. |
Up to approximately 2 years |
|
Secondary |
Combination Dose Expansion in Participants With CLL/SLL: Time to Response |
Time to response is defined by the time between the date of the first drug intake and the date of the first assessment having documented the response. |
Up to approximately 2 years |
|
Secondary |
Combination Dose Expansion in Participants with CLL/SLL: Progression Free Survival |
Progression free survival (PFS) is defined as the duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first. |
Approximately 2 years after study drug discontinuation |
|
Secondary |
Combination Dose Expansion in Participants With CLL/SLL: Overall Survival |
Overall Survival is defined as the number of days from the date the participant was randomized to the date of death. |
Approximately 2 years after study drug discontinuation |
|