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)
← catalyst calendarNCT06428019 · readout ≤ 590 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
170estimated
Sites
70
Countries
Australia, France, Greece +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-05 | actual | When the study began enrolling |
| Primary completion | Mar 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2024-05-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Chronic Lymphocytic Leukemia
Interventions
- Drug: Venetoclax — also filed as ABT-199
- Drug: Acalabrutinib
- Drug: Obinutuzumab
Primary outcomes
what the primary-completion date above is the date OFPart 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-Venetoclax
measured Up to 28 Months
Part 1: Percentage of Participants with Hyperkalemia-Venetoclax
measured Up to 28 Months
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