Spots Global Cancer Trial Database for Study to Assess Effect of Oral Venetoclax Tablet in Combination With Oral Ibrutinib Capsule on Best Overall Response of Complete Response in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma
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Trial Identification
Brief Title: Study to Assess Effect of Oral Venetoclax Tablet in Combination With Oral Ibrutinib Capsule on Best Overall Response of Complete Response in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma
Official Title: Phase 2 Study of the Efficacy and Safety of Venetoclax in Combination With Ibrutinib in Japanese Subjects With Relapsed/Refractory Mantle Cell Lymphoma
Study ID: NCT04477486
Conditions
Study Description
Brief Summary: Mantle Cell Lymphoma (MCL) is a form of Non-Hodgkin Lymphoma (NHL - cancer of the lymphatic system in blood) where cells from outer edge of the lymph nodes, called mantle zone become cancerous. In Japan, MCL accounts for about 3% of all NHL cases. Some symptoms of MCL are enlarged lymph nodes, stomach pain, fever, night sweats, and weight loss. MCL is not curable with standard therapies and has poor outcomes. The purpose of this study is to evaluate the safety, efficacy and effect of venetoclax in combination with ibrutinib on best overall response of complete response in participants with relapsed (return of disease) or refractory (not responding to treatment) (R/R) MCL. Venetoclax is an investigational drug being developed for the treatment of MCL. Ibrutinib is a drug approved for the treatment of MCL. Participants will receive venetoclax (increasing doses) and ibrutinib (fixed dose) for approximately 104 weeks, followed by ibrutinib alone. Adult participants with R/R MCL will be enrolled. Around 12 participants will be enrolled in Japan. Participants will receive oral venetoclax tablet and oral ibrutinib capsule for 104 weeks. After 104 weeks, participants will receive ibrutinib once daily until their disease progresses, or they cannot tolerate the medication, or until they do not want to participate in the study. There may be a higher treatment burden for participants in this study 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, bone marrow biopsies, checking for side effects, and completing questionnaires.
Detailed Description:
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
NHO Nagoya Medical Center /ID# 221958, Nagoya-shi, Aichi, Japan
Aichi Cancer Center Hospital /ID# 221565, Nagoya-shi, Aichi, Japan
Kyushu University Hospital /ID# 223299, Fukuoka-shi, Fukuoka, Japan
Hokkaido University Hospital /ID# 221662, Sapporo-shi, Hokkaido, Japan
Kobe City Medical Center General Hospital /ID# 221744, Kobe-shi, Hyogo, Japan
National Hospital Organization Mito Medical Center /ID# 224912, Higashi Ibaraki-gun, Ibaraki, Japan
Ishikawa Prefectural Central Hospital /ID# 224896, Kanazawa-shi, Ishikawa, Japan
Tohoku University Hospital /ID# 221975, Sendai-shi, Miyagi, Japan
Okayama University Hospital /ID# 221623, Okayama-shi, Okayama, Japan
Saitama Medical Center /ID# 224910, Kawagoe-shi, Saitama, Japan
National Cancer Center Hospital /ID# 221812, Chuo-ku, Tokyo, Japan
Yamagata University Hospital /ID# 221573, Yamagata-shi, Yamagata, Japan
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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