Spots Global Cancer Trial Database for A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML)
Official Title: An Expanded Access Study for Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction Therapy in Japan
Study ID: NCT04509622
Conditions
Study Description
Brief Summary: Acute Myeloid Leukemia (AML) is a cancer of the white blood cells which perform many functions, including fighting bacterial infections and defending the body against parasites. This study will evaluate how safe venetoclax is and assess the adverse events in adult participants with AML. Venetoclax in combination with low-dose cytarabine (LDAC) is an approved therapy in the United States for patients with newly diagnosed acute myeloid leukemia (AML) aged \> 18 years with a medical condition that prevents the use of intensive chemotherapy. This study provides access to venetoclax in combination with LDAC to participants over 18 years who are ineligible for intensive induction therapy. Around 38 adult participants with diagnosis of AML will be enrolled in approximately 15 sites across Japan. Participants will receive oral venetoclax tablets once daily on days 1-28 in combination with subcutaneous low-dose cytarabine (LDAC) injections once daily on days 1-10 of the 28-day treatment cycles. Participants will attend regular visits during the study at a hospital to evaluate safety by medical assessments and blood tests.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
NHO Nagoya Medical Center /ID# 223671, Nagoya-shi, Aichi, Japan
Aichi Cancer Center Hospital /ID# 223134, Nagoya-shi, Aichi, Japan
University of Fukui Hospital /ID# 223133, Yoshida-gun, Fukui, Japan
Kyushu University Hospital /ID# 223136, Fukuoka-shi, Fukuoka, Japan
Gunmaken Saiseikai Maebashi Hospital /ID# 223301, Maebashi-shi, Gunma, Japan
National Hospital Organization Mito Medical Center /ID# 223392, Higashi Ibaraki-gun, Ibaraki, Japan
Hitachi General Hospital /ID# 223084, Hitachi-shi, Ibaraki, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 223135, Kyoto-shi, Kyoto, Japan
Tohoku University Hospital /ID# 223169, Sendai-shi, Miyagi, Japan
Okayama University Hospital /ID# 222990, Okayama-shi, Okayama, Japan
Osaka City University Hospital /ID# 224269, Osaka-shi, Osaka, Japan
Saitama Medical University International Medical Center /ID# 223575, Hidaka-shi, Saitama, Japan
Juntendo University Hospital /ID# 223086, Bunkyo-ku, Tokyo, Japan
The Jikei University Daisan Hospital /ID# 223418, Komae-shi, Tokyo, Japan
NTT Medical Center Tokyo /ID# 223574, Shinagawa-ku, Tokyo, Japan
Yamagata University Hospital /ID# 223032, Yamagata-shi, Yamagata, Japan
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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