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NCT05105841

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)

Completed Phase 2 Last updated 15 October 2025
What this trial tests

Phase 2 trial testing Venetoclax in Chronic Lymphocytic Leukemia (CLL) in 20 participants. Completed in 9 October 2025.

Timeline
8 November 2021
Primary endpoint
9 October 2025
9 October 2025

Quick facts

Lead sponsorAbbVie
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment20
Start date8 November 2021
Primary completion9 October 2025
Estimated completion9 October 2025
Sites20 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

AbbVie — full company profile →

Who can join

20 and older, any sex, with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries, representing approximately 30% of all adult leukemias. There is a large difference in proportion of malignant lymphoma between the United States (US) and Japan was seen in CLL/small lymphocytic lymphoma (SLL) (Japan, 3.2%; US, 24.1%). The purpose of this study is to assess how well venetoclax works in combination with obinutuzumab (V+G, Cohort 1) or with ibrutinib (V+I, Cohort 2) in Japanese participants with previously untreated CLL/Small Lymphocytic Lymphoma (SLL). Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL and SLL. Study doctors put the participants in 1 of 2 groups, called treatment arms, based on variable alternating assignment. Approximately 20 adult participants with previously untreated CLL/SLL will be enrolled in the study in approximately 20 sites in Japan. Participants in group 1 will receive oral venetoclax + intravenous (IV) obinutuzumab (V+G) in 28-day cycles for a total of 12 cycles, and participants in group 2 will receive oral venetoclax + oral ibrutinib (V+I) in 28-day cycles for a total of 15 cycles. 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A phase 2 study of ibrutinib with venetoclax in Japanese patients with untreated CLL and SLL.
    Takizawa J, Yoshida I, Ogawa Y, Toubai T, et al · · 2026 · PMID 41313523 · DOI 10.1007/s12185-025-04114-w
  2. Efficacy and safety of fixed-duration venetoclax plus obinutuzumab in untreated Japanese CLL and SLL: a phase 2 study.
    Izutsu K, Watanabe M, Toubai T, Tsukamoto T, et al · · 2026 · PMID 41212498 · DOI 10.1007/s12185-025-04095-w

Verify or expand the search:

Other trials of Venetoclax

Trials testing the same drug.

Other recruiting trials for Chronic Lymphocytic Leukemia (CLL)

Currently open trials in the same condition.

Other AbbVie trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05105841.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing