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Brief Title: 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)
Official Title: 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)
Study ID: NCT05105841
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.
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
NHO Nagoya Medical Center /ID# 233523, Nagoya-shi, Aichi, Japan
Aichi Cancer Center Hospital /ID# 238797, Nagoya-shi, Aichi, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 233524, Nagoya-shi, Aichi, Japan
Chiba Cancer Center /ID# 238839, Chiba-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center /ID# 234059, Matsuyama-shi, Ehime, Japan
Kyushu University Hospital /ID# 238437, Fukuoka-shi, Fukuoka, Japan
Hokkaido University Hospital /ID# 238377, Sapporo-shi, Hokkaido, Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 234082, Amagasaki-shi, Hyogo, Japan
Tokai University Hospital /ID# 238970, Isehara-shi, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 239883, Kyoto-shi, Kyoto, Japan
Tohoku University Hospital /ID# 238433, Sendai-shi, Miyagi, Japan
Niigata University Medical & Dental Hospital /ID# 238324, Niigata-shi, Niigata, Japan
Okayama University Hospital /ID# 238467, Okayama-shi, Okayama, Japan
Kindai University Hospital /ID# 234001, Osakasayama-shi, Osaka, Japan
Osaka University Hospital /ID# 234037, Suita-shi, Osaka, Japan
Shimane University Hospital /ID# 234076, Izumo-shi, Shimane, Japan
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-shi, Yamagata, Japan
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR