Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax in Combination With Intravenous (IV) Obinutuzumab or Oral Ibrutinib in Adult Participants With Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
20actual
Sites
20
Country
Japan
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 | 2021-11-08 | actual | When the study began enrolling |
| Primary completion | 2025-10-09 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-09 | actual | The whole study's end, after follow-up |
| First posted | 2021-11-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Small Lymphocytic Lymphoma (SLL)
Interventions
- Drug: Venetoclax — also filed as Venclexta, ABT-199, GDC-0199
- Drug: Ibrutinib — also filed as Imbruvica
- Drug: Obinutuzumab — also filed as GA101, Gazyva, RO5072759
Primary outcomes
what the primary-completion date above is the date OFComplete Remission (CR) with an Incomplete Marrow Recovery (CRi) Rate, as Assessed by an Independent Review Committee (IRC) per Modified 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) for Venetoclax + Obinutuzumab (V+G)
measured Up to Week 32
CR/CRi Rate, as Assessed by an IRC per iwCLL for Venetoclax + Ibrutinib (V+I)
measured Up to Week 56
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