Spots Global Cancer Trial Database for Study to Assess Adverse Events and Change in Disease State of Oral Venetoclax in Combination With Subcutaneous (SC) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy in China
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Trial Identification
Brief Title: Study to Assess Adverse Events and Change in Disease State of Oral Venetoclax in Combination With Subcutaneous (SC) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy in China
Official Title: A Phase 4 Study of Venetoclax in Combination With Azacitidine in Newly Diagnosed Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy in China
Study ID: NCT05144243
Conditions
Study Description
Brief Summary: Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo intensive chemotherapy, the current standard of care. This study is to evaluate how safe the combination of azacitidine and venetoclax is and how effective the combination of azacitidine and venetoclax is in adult participants with acute myeloid leukemia (AML), in China. Adverse events and change in disease state will be assessed. The combination of azacitidine and venetoclax is being evaluated in the treatment of acute myeloid leukemia (AML). Participants will receive azacitidine with increasing doses of venetoclax. Adult participants with a diagnosis of AML will be enrolled. Around 40 participants will be enrolled in the study in approximately 30 sites in China. At cycle 1 during ramp-up period, participants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved on day 3. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous injection (SC) for 7 days beginning on Day 1 of each 28-day cycle. 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: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking Union Medical College Hospital /ID# 233179, Beijing, Beijing, China
Sun Yat-Sen University Cancer Center /ID# 231793, Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University /ID# 231792, Guangzhou, Guangdong, China
Guangdong Second Provincial General Hospital /ID# 232059, Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 231938, Guangzhou, Guangdong, China
Shenzhen Second People's Hospital /ID# 231444, Shenzhen, Guangdong, China
Henan Provincial People's Hospital /ID# 232568, Zhengzhou, Henan, China
Henan Cancer Hospital /ID# 231940, Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233178, Wuhan, Hubei, China
Xiangyang Central Hospital /ID# 232452, Xiangyang, Hubei, China
The First Affiliated Hospital of Soochow University /ID# 232418, Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 231442, Nanchang, Jiangxi, China
Qinghai University Affiliated Hospital /ID# 232419, Xining, Qinghai, China
The Second People's Hospital of Yibin /ID# 233180, Yibin, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 232253, Tianjin, Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University /ID# 233704, Wenzhou, Zhejiang, China
Peking University International Hospital /ID# 232254, Beijing, , China
The Affiliated Hospital of Guizhou Medical University /ID# 232465, Guiyang, , China
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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