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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

Acute Myeloid Leukemia (AML) Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05144243
Study type Interventional
Source AbbVie
Contact
Status Active, not recruiting
Phase Phase 4
Start date January 6, 2022
Completion date July 28, 2024
View Details
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