protocolSection identificationModule nctId: NCT06291220, orgStudyIdInfo id: M24-291, secondaryIdInfos id: 2023-507637-19, type: OTHER, domain: EU CT, briefTitle: A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-02, primaryCompletionDateStruct date: 2029-07-21, completionDateStruct date: 2029-07-21, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in disease activity will be assessed.ABBV-453 is an investigational drug for the treatment of CLL and SLL. There are 2 parts to this study. In part A participants will be placed 1 of 5 cohorts with a specific target dose for each cohort and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. In part B participants will be placed in 2 cohorts and receive up to the maximum dose in part A, with cohort 2.1 including a debulking period (obinutuzumab) as in part A. Approximately 80 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 28 sites across the world.Participants in part A will placed into 1 of 5 cohorts with a specific target dose for each cohort and will receive intravenous (IV) obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the appropriate target dose is achieved. Participants in part B will be place in one of 2 cohorts. Participants in cohort 2.1 will receive IV obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. Participants in cohort 2.2 will receive no treatment during the the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. The estimated study duration is 5 years.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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects., conditionsModule conditions: Chronic Lymphocytic Leukemia, conditions: Small Lymphocytic Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Obinutuzumab, interventions name: ABBV-453, outcomesModule primaryOutcomes measure: Part A and B: Percentage of Participants With Adverse Events (AEs), primaryOutcomes measure: Part A: Maximum Administered Dose (MAD) of ABBV-453, primaryOutcomes measure: Part A: Maximum Tolerated Dose (MTD) of ABBV-453, secondaryOutcomes measure: Part A and B: Maximum Observed Plasma Concentration (Cmax) of ABBV-453, secondaryOutcomes measure: Part A and B: Time to Maximum Observed Concentration (Tmax) of ABBV-453, secondaryOutcomes measure: Part A and B: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-453, secondaryOutcomes measure: Part A and B: Overall Response Rate (ORR), secondaryOutcomes measure: Part A and B: Duration of Response (DOR) for Participants with PR/nPR or Better, secondaryOutcomes measure: Part A and B: Complete response rate (CRR), secondaryOutcomes measure: Part A and B: Duration of Complete Response (DOCR), secondaryOutcomes measure: Part A and B: Percentage of Participants Achieving an Minimal Residual Disease (MRD) Response among Participants Achieving a PR, nPR, CR, or CRi, secondaryOutcomes measure: Part A and B: Progression-free survival (PFS), secondaryOutcomes measure: Part A and B: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False