Ruxolitinib-Decitabine Intensified Conditioning Regimen for AML: A Randomized Trial

Summary

This study aims to determine whether the recurrence rate of high-risk acute myeloid leukemia CR1 patients who received allogeneic hematopoietic stem cell transplantation with the Ruxolitinib, Decitabine combined with Bu/Cy or BuF intensive pretreatment regimen is reduced compared with the traditional Bu/Cy or BuFpretreatment regimen.

Timeline

Start

2025-01-01

Primary completion

2028-01-01

Completion

2028-12-30

Publications

• Background Xuan L, Dai M, Jiang E, Wang Y, Huang F, Fan Z, Xu N, Nie D, Liang X, Chen H, Ye J, Shi P, Liu H, Jin H, Lin R, Yan C, Zhang Y, Sun J, Han M, Liu Q. The effect of granulocyte-colony stimulating factor, decitabine, and busulfan-cyclophosphamide versus busulfan-cyclophosphamide conditioning on relapse in patients with myelodysplastic syndrome or secondary acute myeloid leukaemia evolving from myelodysplastic syndrome undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2023 Mar;10(3):e178-e190. doi: 10.1016/S2352-3026(22)00375-1. Epub 2023 Jan 23.
• Background Li Z, Shi W, Lu X, Lu H, Cao X, Tang L, Yan H, Zhong Z, You Y, Xia L, Hu Y, Wang H. Decitabine-Intensified Modified Busulfan/Cyclophosphamide Conditioning Regimen Improves Survival in Acute Myeloid Leukemia Patients Undergoing Related Donor Hematopoietic Stem Cell Transplantation: A Propensity Score Matched Analysis. Front Oncol. 2022 Mar 16;12:844937. doi: 10.3389/fonc.2022.844937. eCollection 2022.
• Background Watanabe T. [Drug tolerance in microorganisms, with special reference to genetic study of its transmission]. Nihon Saikingaku Zasshi. 1969 Oct;24(9):418-25. No abstract available. Japanese.
• Background Tang X, Valdez BC, Ma Y, Zhang Q, Qu C, Dai H, Yin J, Li Z, Xu T, Xu Y, Chen J, Zhu X, Chen Z, Wu D, Andersson BS. Low-dose decitabine as part of a modified Bu-Cy conditioning regimen improves survival in AML patients with active disease undergoing allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2021 Jul;56(7):1674-1682. doi: 10.1038/s41409-021-01238-5. Epub 2021 Feb 26.
• Background Tsukada T, Fukushima M, Takebe H, Nakai Y. Vasoactive intestinal peptide gene expression in the rat pheochromocytoma cell line PC12. Mol Cell Endocrinol. 1995 Feb;107(2):231-9. doi: 10.1016/0303-7207(94)03448-3.
• Background Schmid C, Schleuning M, Schwerdtfeger R, Hertenstein B, Mischak-Weissinger E, Bunjes D, Harsdorf SV, Scheid C, Holtick U, Greinix H, Keil F, Schneider B, Sandherr M, Bug G, Tischer J, Ledderose G, Hallek M, Hiddemann W, Kolb HJ. Long-term survival in refractory acute myeloid leukemia after sequential treatment with chemotherapy and reduced-intensity conditioning for allogeneic stem cell transplantation. Blood. 2006 Aug 1;108(3):1092-9. doi: 10.1182/blood-2005-10-4165. Epub 2006 Mar 21.
• Background Pankhurst R. The earliest history of famine and pestilence in Ethiopia and a note on the "Egyptian Deaths" of 17th and 18th century Ethiopia. Ethiop Med J. 1973 Jul;11(3):233-6. No abstract available.
• Background Thomas HC, McSween RN, White RG. Role of the liver in controlling the immunogenicity of commensal bacteria in the gut. Lancet. 1973 Jun 9;1(7815):1288-91. doi: 10.1016/s0140-6736(73)91300-7. No abstract available.
• Background Camera A, Rinaldi CR, Palmieri S, Cantore N, Mele G, Mettivier V, Miraglia E, Mastrullo L, Grimaldi F, Luciano L, Guerriero A, Rotoli B, Ferrara F. Sequential continuous infusion of fludarabine and cytarabine associated with liposomal daunorubicin (DaunoXome) (FLAD) in primary refractory or relapsed adult acute myeloid leukemia patients. Ann Hematol. 2009 Feb;88(2):151-8. doi: 10.1007/s00277-008-0571-z. Epub 2008 Aug 16.
• Background Fiegl M, Unterhalt M, Kern W, Braess J, Spiekermann K, Staib P, Gruneisen A, Wormann B, Schondube D, Serve H, Reichle A, Hentrich M, Schiel X, Sauerland C, Heinecke A, Rieger C, Beelen D, Berdel WE, Buchner T, Hiddemann W; German AML Cooperative Group (AMLCG). Chemomodulation of sequential high-dose cytarabine by fludarabine in relapsed or refractory acute myeloid leukemia: a randomized trial of the AMLCG. Leukemia. 2014 May;28(5):1001-7. doi: 10.1038/leu.2013.297. Epub 2013 Oct 22.

Drugs

Indications