Pegcrisantaspase in Combination With Venetoclax for Treatment of Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)

Summary

Evaluate the safety and tolerability of pegcrisantaspase in combination with venetoclax (Ven-PegC) and estimate the maximum tolerated doses and/or biologically active doses of Ven-PegC in patients with relapsed or refractory acute myeloid leukemia (R/R AML)

Timeline

Start

2021-03-10

Primary completion

2024-09-01

Completion

2025-05-23

Publications

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• Background Willems L, Jacque N, Jacquel A, Neveux N, Maciel TT, Lambert M, Schmitt A, Poulain L, Green AS, Uzunov M, Kosmider O, Radford-Weiss I, Moura IC, Auberger P, Ifrah N, Bardet V, Chapuis N, Lacombe C, Mayeux P, Tamburini J, Bouscary D. Inhibiting glutamine uptake represents an attractive new strategy for treating acute myeloid leukemia. Blood. 2013 Nov 14;122(20):3521-32. doi: 10.1182/blood-2013-03-493163. Epub 2013 Sep 6.
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• Background Patzke CL, Duffy AP, Duong VH, El Chaer F, Trovato JA, Baer MR, Bentzen SM, Emadi A. Comparison of High-Dose Cytarabine, Mitoxantrone, and Pegaspargase (HAM-pegA) to High-Dose Cytarabine, Mitoxantrone, Cladribine, and Filgrastim (CLAG-M) as First-Line Salvage Cytotoxic Chemotherapy for Relapsed/Refractory Acute Myeloid Leukemia. J Clin Med. 2020 Feb 16;9(2):536. doi: 10.3390/jcm9020536.
• Background Emadi A, Law JY, Strovel ET, Lapidus RG, Jeng LJB, Lee M, Blitzer MG, Carter-Cooper BA, Sewell D, Van Der Merwe I, Philip S, Imran M, Yu SL, Li H, Amrein PC, Duong VH, Sausville EA, Baer MR, Fathi AT, Singh Z, Bentzen SM. Asparaginase Erwinia chrysanthemi effectively depletes plasma glutamine in adult patients with relapsed/refractory acute myeloid leukemia. Cancer Chemother Pharmacol. 2018 Jan;81(1):217-222. doi: 10.1007/s00280-017-3459-6. Epub 2017 Nov 8.
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• Background Nguyen HA, Su Y, Zhang JY, Antanasijevic A, Caffrey M, Schalk AM, Liu L, Rondelli D, Oh A, Mahmud DL, Bosland MC, Kajdacsy-Balla A, Peirs S, Lammens T, Mondelaers V, De Moerloose B, Goossens S, Schlicht MJ, Kabirov KK, Lyubimov AV, Merrill BJ, Saunthararajah Y, Van Vlierberghe P, Lavie A. A Novel l-Asparaginase with low l-Glutaminase Coactivity Is Highly Efficacious against Both T- and B-cell Acute Lymphoblastic Leukemias In Vivo. Cancer Res. 2018 Mar 15;78(6):1549-1560. doi: 10.1158/0008-5472.CAN-17-2106. Epub 2018 Jan 17.
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• Liu Y, Bollino DR, Bah OM, Strovel ET, Le TV, Zarrabi J, Philip S, Lapidus RG, Baer MR, Niyongere S, Duong VH, Dougherty CC, Beumer JH, Caprinolo KD, Kamangar F, Emadi A. A phase 1 study of the amino acid modulator pegcrisantaspase and venetoclax for relapsed or refractory acute myeloid leukemia. Blood. 2025 Jan 30;145(5):486-496. doi: 10.1182/blood.2024024837.

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Indications