Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants of Any Age With Acute Myeloid Leukemia

Study Identifier
P20-408
CT.gov Identifier
NCT04813263
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- All participants who are administered venetoclax for treatment of AML.
    Exclusion Criteria:
    None

    Protocol Summary

    Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. 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 to treat Acute Myeloid Leukemia (AML). Around 400 participants of any age who are treated with oral venetoclax tablets for AML in accordance with the approved label will be enrolled in the study across Japan.

    Participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets.

    There is expected to be no additional burden for participants in this study. Data will be collected by information provided by participating physicians based on routine medical records.

    Study Locations

    Location
    Status
    Location
    Anjou Kousei Hospital /ID# 244213
    Anjo-shi, Aichi-ken, Japan, 446-8602
    Status
    Not applicable
    Location
    Nagoya City West Medical Center /ID# 250844
    Nagoya, Aichi-ken, Japan, 462-8508
    Status
    Not applicable
    Location
    Aichi Cancer Center Hospital /ID# 243785
    Nagoya, Aichi-ken, Japan, 464-8681
    Status
    Not applicable
    Location
    Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 242173
    Nagoya, Aichi-ken, Japan, 466-8650
    Status
    Not applicable
    Location
    Nagoya University Hospital /ID# 246009
    Nagoya, Aichi-ken, Japan, 4668560
    Status
    Not applicable
    Location
    Nagoya City University Hospital /ID# 256177
    Nagoya, Aichi-ken, Japan, 467-8602
    Status
    Not applicable
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