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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)
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.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
November 8, 2021
Primary Completion Date
October 9, 2025
Completion Date
October 9, 2025
Last Updated
October 15, 2025
20
ACTUAL participants
Venetoclax
DRUG
Ibrutinib
DRUG
Obinutuzumab
DRUG
Lead Sponsor
AbbVie
NCT06043011
NCT06528301
Data Source & Attribution
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