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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Tablet: Oral
Subcutaneous Injection (SC)
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 233179
Beijing, Beijing Municipality, China
Peking University International Hospital /ID# 232254
Beijing, Beijing Municipality, 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
People's Hospital of Henan Province /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
...and 8 more locations
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Time frame: Up to Approximately 19 Months
Number of Laboratory Abnormalities from Clinical Laboratory Values (Hematology and Chemistry)
Number of Laboratory abnormalities from clinical laboratory values (hematology and chemistry).
Time frame: Up to Approximately 19 Months
Percentage of Participants with Composite Complete Remission (CR [Complete Remission] + CRi [Complete Remission with Incomplete Blood Count Recovery]) Based on the Modified International Working Group (IWG) Criteria for Acute Myeloid Leukemia (AML)
CR + CRi is defined as achieving a CR or CRi at any time point during the study prior to the start of post-treatment anti-AML therapies per the modified IWG criteria for AML. CR is defined as absolute neutrophil count (ANC) \> 10\^3/μL, platelets \> 10\^5/μL, red cell transfusion independence, and bone marrow with \< 5% blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi is defined as all of the criteria for CR except for residual neutropenia \<= 10\^3/μL (1000/μL) or thrombocytopenia \<= 10\^5/μL (100,000/μL). Red blood cell (RBC) transfusion dependence is also defined as CRi.
Time frame: Up to Approximately 19 Months
Percentage of Participants with CR based on the modified IWG criteria for AML
CR is defined as absolute neutrophil count (ANC) \> 10\^3/μL, platelets \> 10\^5/μL, red cell transfusion independence, and bone marrow with \< 5% blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.
Time frame: Up to Approximately 19 Months
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