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

Study Identifier
M23-826
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
  • Study Drug
  • Venetoclax
  • Azacitidine
  • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Fortis Memorial Research Institute /ID# 268697
    Gurgaon, Haryana, India, 122002
    Status
    Recruiting
    Location
    Mazumdar Shaw Medical Center /ID# 270677
    Bengaluru, Karnataka, India, 560099
    Status
    Recruiting
    Location
    Regional Cancer Centre /ID# 268785
    Thiruvananthapuram, Kerala, India, 695011
    Status
    Recruiting
    Location
    LMMF's Deenanath Mangeshkar Hospital & Research Center /ID# 268781
    Pune, Maharashtra, India, 411004
    Status
    Recruiting
    Location
    Sahyadri Super Speciality Hospital /ID# 272074
    Pune, Maharashtra, India, 411004
    Status
    Recruiting
    Location
    All India Institute Of Medical Sciences - New Delhi /ID# 268357
    New Delhi, National Capital Territory of Delhi, India, 110029
    Status
    Recruiting
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