A phase II study of bisantrene in patients with relapsed/refractory acute myeloid leukemia

Jonathan Canaani, Ivetta Danylesko, Noga Shemtov, Maya Zlotnick, Kira Lozinsky, Ohad Benjamini, Ronit Yerushalmi, Meital Nagar, Chen Dor, Avichai Shimoni, Abraham Avigdor, Arnon Nagler*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


Objectives: To determine the current role of bisantrene, an anthracene with anthracycline-like activity which was shown in earlier studies to be effective therapy in relapsed/refractory acute myeloid leukemia with no discernible cardiotoxicity, in the treatment of patients with R/R AML. Methods: This phase 2, single-center study (NCT03820908) enrolled adult R/R AML to receive bisantrene (250 mg/m2 daily for 7 days) which was administered via an intravenous infusion over 2 hours on days 1-7. Disease assessment included routine blood work and bone marrow studies. Results: In all, 10 patients were enrolled with a median of 3 lines of prior therapy including seven patients who had relapsed following allogeneic stem cell transplantation. The most frequently reported grade ≥3 treatment-attributed hematologic AE was thrombocytopenia, whereas the most frequently reported grade ≥3 treatment-attributed non-hematologic AE was mucositis. Of the 10 patients, one (10%) achieved a complete remission and three patients achieved a partial remission resulting in an overall response rate of 40%. Next-generation sequencing of patient samples identified a wide array of mutations associated with activated signaling, splicing, and epigenetic modification. Conclusions: In view of the observed low toxicity, a follow-up study combining bisantrene with complementary anti-leukemic therapy is planned.

Original languageEnglish
Pages (from-to)260-266
Number of pages7
JournalEuropean Journal of Haematology
Issue number2
StatePublished - Feb 2021


FundersFunder number
Race Oncology, Ltd.


    • acute myeloid leukemia
    • clinical trials
    • molecular cytogenetics


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