Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Immune Response and MRD in Acute Myeloid Leukemia

Summary

Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission. This is an international, multicenter, open-label study to evaluate the effects of remission maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune system cells (T and NK cells) and prospectively defined markers of immune response that are known to reflect T and NK cell ability to combat AML.

Timeline

Start

2009-07

Primary completion

2014-06

Completion

2014-06

Publications

• Hussein BA, Hallner A, Wennstrom L, Brune M, Martner A, Hellstrand K, Bernson E, Thoren FB. Impact of NK Cell Activating Receptor Gene Variants on Receptor Expression and Outcome of Immunotherapy in Acute Myeloid Leukemia. Front Immunol. 2021 Dec 9;12:796072. doi: 10.3389/fimmu.2021.796072. eCollection 2021.
• Grauers Wiktorin H, Aydin E, Christenson K, Issdisai N, Thoren FB, Hellstrand K, Martner A. Impact of IL-1beta and the IL-1R antagonist on relapse risk and survival in AML patients undergoing immunotherapy for remission maintenance. Oncoimmunology. 2021 Jul 25;10(1):1944538. doi: 10.1080/2162402X.2021.1944538. eCollection 2021.
• Grauers Wiktorin H, Nilsson MS, Kiffin R, Sander FE, Lenox B, Rydstrom A, Hellstrand K, Martner A. Histamine targets myeloid-derived suppressor cells and improves the anti-tumor efficacy of PD-1/PD-L1 checkpoint blockade. Cancer Immunol Immunother. 2019 Feb;68(2):163-174. doi: 10.1007/s00262-018-2253-6. Epub 2018 Oct 12.
• Sander FE, Nilsson M, Rydstrom A, Aurelius J, Riise RE, Movitz C, Bernson E, Kiffin R, Stahlberg A, Brune M, Foa R, Hellstrand K, Thoren FB, Martner A. Role of regulatory T cells in acute myeloid leukemia patients undergoing relapse-preventive immunotherapy. Cancer Immunol Immunother. 2017 Nov;66(11):1473-1484. doi: 10.1007/s00262-017-2040-9. Epub 2017 Jul 18.
• Bernson E, Hallner A, Sander FE, Wilsson O, Werlenius O, Rydstrom A, Kiffin R, Brune M, Foa R, Aurelius J, Martner A, Hellstrand K, Thoren FB. Impact of killer-immunoglobulin-like receptor and human leukocyte antigen genotypes on the efficacy of immunotherapy in acute myeloid leukemia. Leukemia. 2017 Dec;31(12):2552-2559. doi: 10.1038/leu.2017.151. Epub 2017 May 22.
• Rydstrom A, Hallner A, Aurelius J, Sander FE, Bernson E, Kiffin R, Thoren FB, Hellstrand K, Martner A. Dynamics of myeloid cell populations during relapse-preventive immunotherapy in acute myeloid leukemia. J Leukoc Biol. 2017 Aug;102(2):467-474. doi: 10.1189/jlb.5VMA1116-455R. Epub 2017 Feb 24.
• Sander FE, Rydstrom A, Bernson E, Kiffin R, Riise R, Aurelius J, Anderson H, Brune M, Foa R, Hellstrand K, Thoren FB, Martner A. Dynamics of cytotoxic T cell subsets during immunotherapy predicts outcome in acute myeloid leukemia. Oncotarget. 2016 Feb 16;7(7):7586-96. doi: 10.18632/oncotarget.7210.

Drugs

Indications