Maintenance Therapy With Selinexor and Azacitidine in TP53 Mutant AML/MDS After Transplantation

Summary

This study aims to explore the safety and efficacy of selinexor combined with azacitidine for maintenance therapy in TP53 mutant AML/MDS patients following transplantation.

Timeline

Start

2025-06-01

Primary completion

2027-06-30

Completion

2028-12-30

Publications

• Background Mishra A, Tamari R, DeZern AE, Byrne MT, Gooptu M, Chen YB, Deeg HJ, Sallman D, Gallacher P, Wennborg A, Hickman DK, Attar EC, Fernandez HF. Eprenetapopt Plus Azacitidine After Allogeneic Hematopoietic Stem-Cell Transplantation for TP53-Mutant Acute Myeloid Leukemia and Myelodysplastic Syndromes. J Clin Oncol. 2022 Dec 1;40(34):3985-3993. doi: 10.1200/JCO.22.00181. Epub 2022 Jul 11.
• Background Bewersdorf JP, Allen C, Mirza AS, Grimshaw AA, Giri S, Podoltsev NA, Gowda L, Cho C, Tallman MS, Zeidan AM, Stahl M. Hypomethylating Agents and FLT3 Inhibitors As Maintenance Treatment for Acute Myeloid Leukemia and Myelodysplastic Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation-A Systematic Review and Meta-Analysis. Transplant Cell Ther. 2021 Dec;27(12):997.e1-997.e11. doi: 10.1016/j.jtct.2021.09.005. Epub 2021 Sep 20.
• Background Santini V, Stahl M, Sallman DA. TP53 Mutations in Acute Leukemias and Myelodysplastic Syndromes: Insights and Treatment Updates. Am Soc Clin Oncol Educ Book. 2024 Jun;44(3):e432650. doi: 10.1200/EDBK_432650.
• Background Zavras PD, Sinanidis I, Tsakiroglou P, Karantanos T. Understanding the Continuum between High-Risk Myelodysplastic Syndrome and Acute Myeloid Leukemia. Int J Mol Sci. 2023 Mar 6;24(5):5018. doi: 10.3390/ijms24055018.
• Background Najima Y. Overcoming relapse: prophylactic or pre-emptive use of azacitidine or FLT3 inhibitors after allogeneic transplantation for AML or MDS. Int J Hematol. 2023 Aug;118(2):169-182. doi: 10.1007/s12185-023-03596-w. Epub 2023 Apr 10.
• Background Rahme R, Braun T, Manfredi JJ, Fenaux P. TP53 Alterations in Myelodysplastic Syndromes and Acute Myeloid Leukemia. Biomedicines. 2023 Apr 11;11(4):1152. doi: 10.3390/biomedicines11041152.
• Background Patel SA, Cerny J, Gerber WK, Ramanathan M, Ediriwickrema A, Tanenbaum B, Hutchinson L, Meng X, Flahive J, Barton B, Gillis-Smith AJ, Suzuki S, Khedr S, Selove W, Higgins AW, Miron PM, Simin K, Woda B, Gerber JM. Prognostic heterogeneity and clonal dynamics within distinct subgroups of myelodysplastic syndrome and acute myeloid leukemia with TP53 disruptions. EJHaem. 2023 Sep 11;4(4):1059-1070. doi: 10.1002/jha2.791. eCollection 2023 Nov.
• Background Bhansali RS, Pratz KW, Lai C. Recent advances in targeted therapies in acute myeloid leukemia. J Hematol Oncol. 2023 Mar 25;16(1):29. doi: 10.1186/s13045-023-01424-6.
• Background Nawas MT, Kosuri S. Utility or futility? A contemporary approach to allogeneic hematopoietic cell transplantation for TP53-mutated MDS/AML. Blood Adv. 2024 Feb 13;8(3):553-561. doi: 10.1182/bloodadvances.2023010417.
• Background Masuda Y, Sadato D, Toya T, Hosoda Y, Hirama C, Shimizu H, Najima Y, Harada H, Harada Y, Doki N. Transplantation outcomes of TP53-mutant AML and MDS: a single transplantation center experience of 63 patients. Int J Hematol. 2025 Jun;121(6):820-832. doi: 10.1007/s12185-025-03951-z. Epub 2025 Feb 26.

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Indications