A Phase IIa Open-label Clinical Trial to Evaluate the Safety Pharmacokinetics Pharmacodynamics and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination with Venetoclax plus Decitabine in Patients with Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Induction Therapy

Brief description of study

The first purpose of this study is to learn if combining the study drug BP1001 with the standard-of-care drugs Venetoclax and decitabine in first line can help control the disease in patients with AML (acute myeloid leukemia). Another purpose is to learn if the study drug BP1001 plus decitabine and Venetoclax combination can help control the disease in patients with refractory/relapsed AML. BP1001 is a liposome that contains an engineered 5โ€™ โ€“ 3โ€™ 18 deoxyribonucleoside antisense oligonucleotide and is a proprietary nuclease-resistant phosphodiester analog that contains a P-ethoxy backbone. The study drug BP1001 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.

Clinical Study Identifier: s19-01800
ClinicalTrials.gov Identifier: NCT02781883
Principal Investigator: Mohammad Maher Abdul Hay.

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