Study to Assess Adverse Events and Change in Disease Activity of Oral Venetoclax in Combination With Subcutaneous (SC) or Intravenous (IV) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Standard Induction Therapy in India

Condition(s) studied

Investigational drug(s) / intervention(s)

Venetoclax: Oral Tablet

Azacitidine: Subcutaneous (SC) Injection

Azacitidine: Intravenous (IV) Injection

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 standard induction therapy, the current standard of care. This study will assess the change in disease activity and adverse events in adult participants with acute myeloid leukemia (AML) being treated with of the combination of azacitidine and venetoclax, in India.

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. Around 40 adult participants with a diagnosis of AML will be enrolled in the study at approximately 15 sites in India.

Participants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous (SC) or intravenous (IV) injection on Days 1-7 of each cycle. The total study duration is approximately 29 months.

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)

• Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s — Up to Approximately 29 Months
  TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
• Percentage of Participants with Post-Baseline Laboratory Abnormalities — Up to Approximately 29 Months
  Laboratory abnormalities are defined based on the shifts from baseline to postbaseline laboratory values will be summarized using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

Trial sites (14)

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