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Purpose

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 170 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. 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, checking for side effects and completing questionnaires.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of > 6 months. - Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation. - Eastern Cooperative Oncology Group (ECOG) performance status <= 2. - Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol. - Creatinine clearance (CrCl) >= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion.

Exclusion Criteria

  • Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Venetoclax + Obinutuzumab 		Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up.
  • Drug: Venetoclax
    Oral: Tablet
    Other names:
    • ABT-199
  • Drug: Obinutuzumab
    Intravenous Infusion
Experimental
Arm B: Venetoclax + Acalabrutinib 		Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up.
  • Drug: Venetoclax
    Oral: Tablet
    Other names:
    • ABT-199
  • Drug: Acalabrutinib
    Oral: Tablet
Experimental
Arm C: Venetoclax + Acalabrutinib 		Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up A.
  • Drug: Venetoclax
    Oral: Tablet
    Other names:
    • ABT-199
  • Drug: Acalabrutinib
    Oral: Tablet
Experimental
Arm D: Venetoclax + Acalabrutinib 		Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up B.
  • Drug: Venetoclax
    Oral: Tablet
    Other names:
    • ABT-199
  • Drug: Acalabrutinib
    Oral: Tablet

Recruiting Locations

UMass Memorial Medical Center /ID# 270023
Worcester, Massachusetts 01605

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.