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A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

StatusRecruiting
PhasePhase 3
SponsorAbbVie
Started2024-08-05
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 50 times since 2024-05-20; most recent filed 2026-04-06. The 50 most recent of 51 record versions are listed below. See every version on ClinicalTrials.gov ↗

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-04-06
Amendment Study Status, Contacts/Locations v50
2025-11-04
Amendment Study Status, Study Description, Study Design, IPDSharing v49
2025-09-11
Amendment Study Status, Contacts/Locations v48
2025-08-22
Amendment Study Status, Contacts/Locations v47
2025-08-21
Amendment Study Status, Contacts/Locations v46
2025-07-29
Amendment Study Status, Contacts/Locations v45
2025-07-21
Amendment Study Status, Contacts/Locations v44
2025-07-11
Amendment Study Status, Contacts/Locations v43
2025-07-01
Amendment Study Status, Contacts/Locations v42
2025-06-30
Amendment Study Status v41
2025-05-21
Amendment Study Status v40
2025-05-01
Amendment Study Status, Contacts/Locations v39
2025-04-23
Amendment Study Status, Contacts/Locations v38
2025-04-10
Amendment Study Status, Contacts/Locations v37
2025-03-13
Amendment Study Status, Contacts/Locations v36
2025-03-12
Amendment Study Status, Contacts/Locations v35
2025-03-10
Amendment Study Status, Outcome Measures, Contacts/Locations v34
2025-02-03
Amendment Study Status, Contacts/Locations v33
2025-01-30
Amendment Study Status, Contacts/Locations v32
2025-01-29
Amendment Study Status, Contacts/Locations v31
2025-01-27
Amendment Study Status, Contacts/Locations v30
2025-01-27
Amendment Study Status, Contacts/Locations v29
2025-01-22
Amendment Study Status, Contacts/Locations v28
2025-01-16
Amendment Study Status, Contacts/Locations v27
2025-01-15
Amendment Study Status, Contacts/Locations v26
2025-01-10
Amendment Study Status, Contacts/Locations v25
2025-01-09
Amendment Study Status, Contacts/Locations v24
2025-01-03
Amendment Study Status v23
2024-12-30
Amendment Study Status, Contacts/Locations v22
2024-12-18
Amendment Study Status, Contacts/Locations v21
2024-12-16
Amendment Study Status, Contacts/Locations v20
2024-12-11
Amendment Study Status, Contacts/Locations v19
2024-12-06
Amendment Study Status, Contacts/Locations v18
2024-12-05
Amendment Study Status, Contacts/Locations v17
2024-12-02
Amendment Study Status, Contacts/Locations v16
2024-11-22
Amendment Study Status, Contacts/Locations v15
2024-11-15
Amendment Study Status, Contacts/Locations v14
2024-11-05
Amendment Study Status, Contacts/Locations v13
2024-11-01
Amendment Study Status, Contacts/Locations v12
2024-10-30
Amendment Study Status, Contacts/Locations v11
2024-10-29
Amendment Study Status, Contacts/Locations v10
2024-10-28
Amendment Study Status, Contacts/Locations v9
2024-10-21
Amendment Study Status v8
2024-10-17
Amendment Study Status, Contacts/Locations v7
2024-10-10
Amendment Study Status, Contacts/Locations v6
2024-10-07
Amendment Study Status v5
2024-09-23
Amendment Study Status, Contacts/Locations v4
2024-08-08
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v3
2024-07-30
Amendment Study Status, Arms and Interventions, IPDSharing v2
2024-06-27
Amendment Study Status, Eligibility v1
Trial Details
NCT Number NCT06428019
Lead Sponsor AbbVie
Conditions Chronic Lymphocytic Leukemia
Enrollment 170 participants
Start Date 2024-08-05
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-04-09