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Spots Global Cancer Trial Database for 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)

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: ABBVIE INC.

Affiliation: AbbVie

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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