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

Launched by ABBVIE · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for adults in India who have been newly diagnosed with acute myeloid leukemia (AML), a serious type of blood cancer. The study is looking at how safe and effective a combination of two medicines—venetoclax (taken as a pill) and azacitidine (given as an injection)—is for patients who cannot receive the usual strong chemotherapy treatment. Researchers want to see how this combination affects the disease and what side effects might occur.

Adults aged 18 and older with AML who have not had previous treatment and are unable to have intensive chemotherapy may be eligible to join. Participants will take venetoclax pills every day, with doses gradually increasing until the right amount is reached. They will also receive azacitidine injections for seven days in each treatment cycle. The study will last about 29 months, during which participants will have regular hospital visits for check-ups, blood tests, and monitoring for any side effects. Since this treatment may require more hospital visits than usual care, participants should be prepared for that. The trial is not yet recruiting, but about 100 patients across roughly 15 sites in India will take part once it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmation of acute myeloid leukemia (AML) diagnosis by 2016 World Health Organization (WHO) criteria, previously untreated, and ineligible for treatment with intensive chemotherapy.
• * Eastern Cooperative Oncology Group (ECOG) performance status of:
• • 0 to 2 for subject ≥ 75 years of age.
• • 0 to 3 for subject ≥ 18 to 74 years of age.
• Exclusion Criteria:
• • History of any malignancy within 2 years prior to study entry with exception to those noted in the protocol.
• • Have received any investigational drug 30 days prior to the first dose of study drug and have received strong CYP3A inducers within 7 days prior to the initiation of study treatment.