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 Decitabine in Patients with Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS) Who Are Ineligible for Intensive Induction Therapy
MD Anderson Study Status
BP1001 in combination with Ventoclax plus decitabine, BP1001 plus decitabine
The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission [CR], Complete Remission with incomplete hematologic recovery [CRi], Complete Remission with partial hematologic recovery [CRh], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.
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Acute Myeloid Leukemia (AML)
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