biostudies-literatureHolkova BNCATS NIH HHSNCI NIH HHS1187-1194https://www.ebi.ac.uk/biostudies/studies/S-EPMC8106643biostudies-literatureUnknown62(5)We report the results of a phase 1 dose-escalation study of belinostat and bortezomib in adult patients with acute leukemia or MDS or CML with blast crisis. Thirty-eight patients received IV belinostat days 1-5 and 8-12 with IV bortezomib days 1, 4, 8, and 11 every 21 days. QTc prolongation was the only identified DLT. The RP2Ds were 1.3 mg/m² bortezomib and 1000 mg/m² belinostat. One patient with highly refractory <i>MLL-ENL</i> rearranged biphenotypic AML with multiple karyotypic aberrations had a complete pathologic and karyotypic response. One patient with post-MPN AML remained on study with stable disease (SD) for 32 cycles. Whole-exome sequencing revealed no aberrations in the first patient and a hyper-mutator genotype in the second. Eighteen patients had a bestLeukemia & lymphomaPhase 1 study of belinostat (PXD-101) and bortezomib (Velcade, PS-341) in patients with relapsed or refractory acute leukemia and myelodysplastic syndrome.PMC8106643RC2 CA148431R01 CA205607P30 CA016059UL1 TR002649Grant SKmieciak MDave SBandyopadhyay DTombes MBWan WWeir CCollins EBGarcia-Manero GRoberts JDShrader EShafer DHolkova BGarnett AYazbeck VBose PfalsePhase 1 study of belinostat (PXD-101) and bortezomib (Velcade, PS-341) in patients with relapsed or refractory acute leukemia and myelodysplastic syndrome.We report the results of a phase 1 dose-escalation study of belinostat and bortezomib in adult patients with acute leukemia or MDS or CML with blast crisis. Thirty-eight patients received IV belinostat days 1-5 and 8-12 with IV bortezomib days 1, 4, 8, and 11 every 21 days. QTc prolongation was the only identified DLT. The RP2Ds were 1.3 mg/m² bortezomib and 1000 mg/m² belinostat. One patient with highly refractory <i>MLL-ENL</i> rearranged biphenotypic AML with multiple karyotypic aberrations had a complete pathologic and karyotypic response. One patient with post-MPN AML remained on study with stable disease (SD) for 32 cycles. Whole-exome sequencing revealed no aberrations in the first patient and a hyper-mutator genotype in the second. Eighteen patients had a best2021-01-01T00:00:00Z2021 May2026-05-31T21:54:31.799Z2025-02-18T23:32:18.132ZS-EPMC81066433335668910.1080/10428194.2020.1861270