Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants Above 19 Years of Age With Acute Myeloid Leukemia (AML)

Study Identifier
P20-444
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
  • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    19+ years

    Protocol Summary

    Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective oral venetoclax is in participants with AML . Adverse events and change in disease activity will be monitored under routine clinical practice.

    Venetoclax is an approved drug for treatment of Acute Myeloid Leukemia (AML). Around 600 participants of age 19 years and above will be enrolled in the study in multiple medical institutions across South Korea.

    Participants will receive oral venetoclax tablets as prescribed by their physician in the routine clinical practice. Participants will be observed for 7 cycles ( each cycle is 28 days).

    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, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Pusan National University Hospital /ID# 239010
    Busan, Busan Gwang Yeogsi, Republic of Korea, 49241
    Status
    Not applicable
    Location
    Kosin University Gospel Hospital /ID# 257399
    Busan, Busan Gwang Yeogsi, Republic of Korea, 49267
    Status
    Not applicable
    Location
    Kyungpook National University Hospital /ID# 257398
    Daegu, Daegu Gwang Yeogsi, Republic of Korea, 41944
    Status
    Not applicable
    Location
    Gachon University Gil Medical Center /ID# 239008
    Incheon, Gyeonggido, Republic of Korea, 21565
    Status
    Not applicable
    Location
    Chonnam National University Hwasun Hospital /ID# 257478
    Hwasun-gun, Jeonranamdo, Republic of Korea, 58128
    Status
    Not applicable
    Location
    Korea University Anam Hospital /ID# 231022
    Seoul, Seoul Teugbyeolsi, Republic of Korea, 02841
    Status
    Not applicable
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