An open-label, phase I/II trial to determine the maximum tolerated dose and investigate safety, pharmacokinetics and efficacy of BI 836858, an unconjugated anti-CD33 monoclonal antibody, in combination with decitabine in patients with acute myeloid leukemia

Walter Fiedler; Pau Montesinos; Christoph Schliemann; Jan Middeke; Sumithira Vasu; Christian W Scholz; Jordi Esteve; Shoubhik Mondal; Björn Rüter; Ute Burkard; Annika Osswald; William Blum

doi:10.3324/haematol.2022.281128

An open-label, phase I/II trial to determine the maximum tolerated dose and investigate safety, pharmacokinetics and efficacy of BI 836858, an unconjugated anti-CD33 monoclonal antibody, in combination with decitabine in patients with acute myeloid leukemia

Haematologica. 2022 Dec 1;107(12):2977-2982. doi: 10.3324/haematol.2022.281128.

Authors

Affiliations

¹ Department of Oncology, Hematology and Bone Marrow Transplantation with Section Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg.
² Hospital Universitari i Politecnic La Fe, Valencia, Spain; CIBERONC, Instituto Carlos III, Madrid.
³ Department of Medicine A, Hematology and Oncology, University Hospital Muenster, Muenster.
⁴ Uniklinikum Dresden, Dresden.
⁵ Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, OH.
⁶ Department of Hematology and Oncology, Vivantes Klinikum Am Urban, Berlin.
⁷ Hematology Department, Hospital Clínic of Barcelona, IDIBAPS, University of Barcelona, Barcelona.
⁸ Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT.
⁹ BoehringeaBoehringer Ingelheim Pharma GmbH and Co. KG, Biberach/Rissr Ingelheim Pharma GmbH and Co. KG, Biberach/Riss.
¹⁰ Boehringer Ingelheim Pharma GmbH and Co. KG, Biberach/Riss.
¹¹ Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA. william.g.blum@emory.edu.

No abstract available

Publication types

Clinical Trial, Phase II
Clinical Trial, Phase I
Research Support, Non-U.S. Gov't
Letter

MeSH terms

Antibodies, Monoclonal, Humanized / therapeutic use
Antineoplastic Combined Chemotherapy Protocols* / adverse effects
Decitabine / therapeutic use
Humans
Leukemia, Myeloid, Acute* / drug therapy
Maximum Tolerated Dose
Sialic Acid Binding Ig-like Lectin 3

Substances

Antibodies, Monoclonal, Humanized
BI 836858
Decitabine
Sialic Acid Binding Ig-like Lectin 3

Grants and funding

Funding: This work was supported by Boehringer Ingelheim. The sponsor was involved in the study design and the collection, analysis and interpretation of the data. Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. Medical writing support for the development of this manuscript, under the direction of the authors, was provided by Sheridan Henness, and Lynn Pritchard, DPhil, of Ashfield MedComms, an Inizio Company, and was funded by Boehringer Ingelheim.