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A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML)(M19-063)

This study is to determine the recommended Phase 3 dose of venetoclax in combination with azacitidine in Acute Myeloid Leukemia patients when given as maintenance therapy following allogeneic stem cell transplantation. It also is to determine if venetoclax can be effective in combination with azacitidine to improve Relapse Free Survival in Acute Myeloid Leukemia patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation.
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04161885
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Inclusion Criteria:
Adult male or female ≥ 18 years old; and, for Part 2 only, male or female at least 12 years old.
Subject must be diagnosed with Acute Myeloid Leukemia by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic transplantation within the past 14 days.
Subjects that have previously been treated with venetoclax, can only be included if there was no history of disease progression during venetoclax treatment.
Grafts must be from one of the following sources: Bone marrow or peripheral blood stem cells or cord blood cells irrespective of degree of matching.
Subjects and/or their legally authorized representative (where permitted per local regulations) must voluntarily sign and date an informed consent form (and assent form for minors if required by applicable regulations)
Exclusion Criteria:
No malabsorption syndrome or other condition that precludes oral route of administration.
No history of any other malignancy within 2 years prior to study entry
Subject has no known evidence indicating leukemia relapse, which may include immunophenotype, cytogenetic or molecular methods.
No psychiatric illness/social situation that would limit compliance with the study.
No evidence of other clinically significant uncontrolled systemic infection.
Cancer
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Location
Hershey, PA