A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

Study Identifier
M19-063
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2023-507222-17-00
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Results Available

Plain Language Summary
Available Language(s): English, Czech, German (Switzerland), German, Greek, Spanish, French (Switzerland), French, Hungarian, Italian (Switzerland), Italian, Japanese

Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
  • Cancer - Other
  • Study Drug
  • Venetoclax
  • Azacitidine
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    12+ years

    Protocol Summary

    The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT).

    This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).

    Study Locations

    Location
    Status
    Location
    Arizona Oncology - Scottsdale - Cancer Transplant Institute /ID# 239711
    Scottsdale, Arizona, United States, 85258-4547
    Status
    Not applicable
    Location
    University of Arizona Cancer Center - Tucson /ID# 242507
    Tucson, Arizona, United States, 85724
    Status
    Not applicable
    Location
    University of Arkansas for Medical Sciences /ID# 239804
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    City of Hope /ID# 213681
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    UCHSC Anschultz Cancer Pavilion /ID# 215618
    Aurora, Colorado, United States, 80045-2517
    Status
    Not applicable
    Location
    Colorado Blood Cancer Institute /ID# 215980
    Denver, Colorado, United States, 80218
    Status
    Not applicable
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