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
Condition(s) studied
Investigational drug(s) / intervention(s)
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous Injection (SC)
Study 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.
Eligibility
Primary outcome measure(s)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) — Up to Approximately 19 Months
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assesses the relationship of each event to the use of study. - Number of Laboratory Abnormalities from Clinical Laboratory Values (Hematology and Chemistry) — Up to Approximately 19 Months
Number of Laboratory abnormalities from clinical laboratory values (hematology and chemistry).
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 233179 | Beijing | Beijing Municipality | |
| Peking University International Hospital /ID# 232254 | Beijing | Beijing Municipality | |
| Sun Yat-Sen University Cancer Center /ID# 231793 | Guangzhou | Guangdong | |
| Zhujiang Hospital of Southern Medical University /ID# 231792 | Guangzhou | Guangdong | |
| Guangdong Second Provincial General Hospital /ID# 232059 | Guangzhou | Guangdong | |
| Nanfang Hospital of Southern Medical University /ID# 231938 | Guangzhou | Guangdong | |
| Shenzhen Second People's Hospital /ID# 231444 | Shenzhen | Guangdong | |
| People's Hospital of Henan Province /ID# 232568 | Zhengzhou | Henan | |
| Henan Cancer Hospital /ID# 231940 | Zhengzhou | Henan | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233178 | Wuhan | Hubei | |
| Xiangyang Central Hospital /ID# 232452 | Xiangyang | Hubei | |
| The First Affiliated Hospital of Soochow University /ID# 232418 | Suzhou | Jiangsu | |
| The First Affiliated Hospital of Nanchang University /ID# 231442 | Nanchang | Jiangxi | |
| Qinghai University Affiliated Hospital /ID# 232419 | Xining | Qinghai | |
| The Second People's Hospital of Yibin /ID# 233180 | Yibin | Sichuan | |
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 232253 | Tianjin | Tianjin Municipality | |
| The First Affiliated Hospital of Wenzhou Medical University /ID# 233704 | Wenzhou | Zhejiang | |
| Duplicate_The Affiliated Hospital of Guizhou Medical University /ID# 232465 | Guiyang | China |
On this site
📄 Venclexta (venetoclax) drug profile →More AbbVie trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05144243 on ClinicalTrials.gov ↗ ← All trials in China