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

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 d

Trial Details

NCT ID
NCT07044687
Phase
PHASE4
Sponsor
AbbVie
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Venetoclax
  • Azacitidine
Locations (sample)
  • Gurgaon, Haryana, India|28.4601,77.02635
  • Bengaluru, Karnataka, India|12.97194,77.59369
  • Bengaluru, Karnataka, India|12.97194,77.59369
  • Thiruvananthapuram, Kerala, India|8.4855,76.94924
  • Mumbai, Maharashtra, India|19.07283,72.88261

Key Eligibility Criteria

  • Confirmation of acute myeloid leukemia (AML) diagnosis by 2016 World Health Organization (WHO) criteria, previously untreated, and ineligible for t…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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