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)

NCT ID: NCT05105841

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-08
• Study Completion Date: 2025-10-09

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.

Conditions

Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venetoclax + Obinutuzumab (V+G)

Participants will receive venetoclax + obinutuzumab for twelve 28-day cycles.

Group Type: EXPERIMENTAL

Venetoclax

Intervention Type: DRUG

Oral Tablet

Obinutuzumab

Intervention Type: DRUG

Intravenous (IV) Infusion

Venetoclax + Ibrutinib (V+I)

Participants will receive venetoclax + ibrutinib for fifteen 28-day cycles.

Group Type: EXPERIMENTAL

Venetoclax

Intervention Type: DRUG

Oral Tablet

Ibrutinib

Intervention Type: DRUG

Oral Capsule

Interventions

Venetoclax

Oral Tablet

Intervention Type: DRUG

Ibrutinib

Oral Capsule

Intervention Type: DRUG

Obinutuzumab

Intravenous (IV) Infusion

Intervention Type: DRUG

Other Intervention Names

Venclexta; ABT-199; GDC-0199; Imbruvica; GA101; Gazyva; RO5072759

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Duplicate_NHO Nagoya Medical Center /ID# 233523

Nagoya, Aichi-ken, Japan

Aichi Cancer Center Hospital /ID# 238797

Nagoya, Aichi-ken, Japan

Duplicate_Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 233524

Nagoya, Aichi-ken, Japan

Duplicate_Chiba Cancer Center /ID# 238839

Chiba, Chiba, Japan

National Hospital Organization Shikoku Cancer Center /ID# 234059

Matsuyama, Ehime, Japan

Kyushu University Hospital /ID# 238437

Fukuoka, Fukuoka, Japan

Duplicate_Hokkaido University Hospital /ID# 238377

Sapporo, Hokkaido, Japan

Hyogo Prefectural Amagasaki General Medical Center /ID# 234082

Amagasaki-shi, Hyōgo, Japan

Tokai University Hospital /ID# 238970

Isehara, Kanagawa, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 239883

Kyoto, Kyoto, Japan

Tohoku University Hospital /ID# 238433

Sendai, Miyagi, Japan

Niigata University Medical & Dental Hospital /ID# 238324

Niigata, Niigata, Japan

Duplicate_Okayama University Hospital /ID# 238467

Okayama, Okayama-ken, Japan

Kindai University Hospital /ID# 234001

Osakasayama-shi, Osaka, Japan

Duplicate_Osaka University Hospital /ID# 234037

Suita-shi, Osaka, Japan

Duplicate_Shimane University Hospital /ID# 234076

Izumo-shi, Shimane, Japan

Duplicate_Jichi Medical University Hospital /ID# 238434

Shimotsuke-shi, Tochigi, Japan

National Cancer Center Hospital /ID# 232449

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR /ID# 232450

Koto-ku, Tokyo, Japan

Yamagata University Hospital /ID# 234032

Yamagata, Yamagata, Japan

Countries

Japan

Related Links

https://www.rxabbvie.com/

Related info

Other Identifiers

M20-353

Identifier Type: -

Identifier Source: org_study_id