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)
A Phase 2 Study of the Safety and Efficacy of Venetoclax in Combination With Obinutuzumab or Ibrutinib in Japanese Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
1 other identifier
interventional
20
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2021
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedStudy Start
First participant enrolled
November 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2025
CompletedOctober 15, 2025
August 1, 2025
3.9 years
October 25, 2021
October 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Complete 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)
CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
Up to Week 32
CR/CRi Rate, as Assessed by an IRC per iwCLL for Venetoclax + Ibrutinib (V+I)
CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
Up to Week 56
Secondary Outcomes (20)
CR/CRi Rate, as Assessed by an Investigator per iwCLL for (V+G)
Up to Week 32
CR/CRi Rate, as Assessed by an Investigator per iwCLL for (V+I)
Up to Week 56
Overall response rate (ORR) as Assessed by IRC for (V+G)
Up to Week 32
ORR as Assessed by IRC (V+I)
Up to Week 56
ORR as Assessed by Investigator for (V+G)
Up to Week 32
- +15 more secondary outcomes
Study Arms (2)
Venetoclax + Obinutuzumab (V+G)
EXPERIMENTALParticipants will receive venetoclax + obinutuzumab for twelve 28-day cycles.
Venetoclax + Ibrutinib (V+I)
EXPERIMENTALParticipants will receive venetoclax + ibrutinib for fifteen 28-day cycles.
Interventions
Oral Tablet
Intravenous (IV) Infusion
Eligibility Criteria
You may qualify if:
- Adult male or female, at least ≥ 65 years old; or 20 to 64 years old and have at least 1 of the following:
- Cumulative Illness Rating Scale (CIRS) score \> 6.
- Creatinine clearance (CrCl) estimated \< 70 mL/min using Cockcroft-Gault equation.
- Must have measurable nodal disease (by computed tomography \[CT\]), defined as at least one lymph node \> 1.5 cm in longest diameter.
- Diagnosed Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that requires treatment according to the Modified 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
You may not qualify if:
- Transformation of Chronic Lymphocytic Leukemia (CLL) to aggressive non-Hodgkin lymphoma (NHL; Richter's transformation or pro-lymphocytic leukemia).
- Previous treatment history for CLL/SLL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (20)
Duplicate_NHO Nagoya Medical Center /ID# 233523
Nagoya, Aichi-ken, 460-0001, Japan
Aichi Cancer Center Hospital /ID# 238797
Nagoya, Aichi-ken, 464-8681, Japan
Duplicate_Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 233524
Nagoya, Aichi-ken, 466-8650, Japan
Duplicate_Chiba Cancer Center /ID# 238839
Chiba, Chiba, 260-8717, Japan
National Hospital Organization Shikoku Cancer Center /ID# 234059
Matsuyama, Ehime, 791-0280, Japan
Kyushu University Hospital /ID# 238437
Fukuoka, Fukuoka, 812-8582, Japan
Duplicate_Hokkaido University Hospital /ID# 238377
Sapporo, Hokkaido, 060-8648, Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 234082
Amagasaki-shi, Hyōgo, 660-8550, Japan
Tokai University Hospital /ID# 238970
Isehara, Kanagawa, 259-1193, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 239883
Kyoto, Kyoto, 602-8566, Japan
Tohoku University Hospital /ID# 238433
Sendai, Miyagi, 9808574, Japan
Niigata University Medical & Dental Hospital /ID# 238324
Niigata, Niigata, 951-8520, Japan
Duplicate_Okayama University Hospital /ID# 238467
Okayama, Okayama-ken, 700-8558, Japan
Kindai University Hospital /ID# 234001
Osakasayama-shi, Osaka, 589-8511, Japan
Duplicate_Osaka University Hospital /ID# 234037
Suita-shi, Osaka, 565-0871, Japan
Duplicate_Shimane University Hospital /ID# 234076
Izumo-shi, Shimane, 693-8501, Japan
Duplicate_Jichi Medical University Hospital /ID# 238434
Shimotsuke-shi, Tochigi, 329-0498, Japan
National Cancer Center Hospital /ID# 232449
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital Of JFCR /ID# 232450
Koto-ku, Tokyo, 135-8550, Japan
Yamagata University Hospital /ID# 234032
Yamagata, Yamagata, 990-9585, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 25, 2021
First Posted
November 3, 2021
Study Start
November 8, 2021
Primary Completion
October 9, 2025
Study Completion
October 9, 2025
Last Updated
October 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.