CC-486 and Venetoclax for Acute Myeloid Leukemia
University of Colorado, Denver
35 participants
Dec 19, 2022
INTERVENTIONAL
Conditions
Summary
This is an open label, dose escalation Phase I single institution pilot study for relapsed and refractory AML patients using CC-486 (oral azacitidine) with venetoclax. At the completion of dose escalation and after establishment of the MTD or recommended dose of CC-486 with venetoclax, an expansion phase will commence, using venetoclax with the MTD of CC-486 in relapsed/refractory patients.
Eligibility
Plain Language Summary
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Interventions
Venetoclax is a potent, selective and orally bioavailable small molecule inhibitor of BCL-2 that binds with \> 1,000-fold higher affinity to BCL-2 (Ki \< 0.010 nM) than other apoptotic pathway proteins BCL-XL (Ki = 48 nm) or MCL-1 (Ki \> 444 nM). Leukemia stem cells (LSCs) overexpress BCL-2, and BCL-2 overexpression has been associated with worse outcomes in AML.
An oral formulation of azacitidine currently being developed for the treatment of hematological and solid malignancies.
Locations(2)
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NCT05287568