Sheba Medical Center Brief Summary: An Open-label, Phase II,...

Sheba Medical Center


Brief Summary: An Open-label, Phase II, Two-stage, Study of Xantrene® (Bisantrene) in combination with Fludarabine and Clofarabine as Salvage Therapy for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) Lead-in stage: up to 12 (up to 2 cohorts in a 3+3 dose escalation design) Efficacy stage: up to 17 (Simon 2-stage design 9+8) Study Objectives: Confirm safety and tolerability of the combination regimen Time to response with combination treatment Overall survival The treatment regimen will comprise daily IV infusion of Fludarabine (Flu), Clofarabine (Clo) and Bisantrene (Xan) administered via central venous line and controlled-rate infusion pump with a 1-hour break between each agent infusion, amounting to a total of 6 hours for each daily FluCloXan treatment in the following sequence: First, infusion over 60 minutes of Fludarabine (Flu) at 10 mg/m2 Followed by infusion of Clofarabine (Clo) at 30 mg/m2 over 60 minutes Followed by infusion of Bisantrene (Xan) at 250 mg/m2 over 2 hours. One cycle will comprise daily IV infusion of the combination treatment course for 4 or 5 consecutive days and rest period to between Day 30 and Day 42, based on patient performance and disease status.

Actual Study Start Date : August 2, 2021 Estimated Primary Completion Date : December 1, 2024 Estimated Study Completion Date : December 1, 2025

Fludarabine - Avera Pharmaceuticals (American Company)
https://www.csrxp.org/big-pharma-watch-drug-maker-prices-chemo-treatment-ten-times-above-the-market-as-patients-face-shortages/

This week, Areva Pharmaceuticals, a U.S.-based drugmaker, brought an older oncology treatment to market used for patients suffering from certain forms of Leukemia. According to reports, the drug, fludarabine, has been in short supply and hospitals and cancer centers have struggled to secure supplies of the drug. Areva Pharmaceuticals began marketing the drug at a price of $2,736 – more than 10 times what other drug makers charge for the same drug, between $109 and $272.

Clofarabine- Ilex Oncology was taking over by Genzyme in 2004. Sanofi (giant French company) acquired Genzyme in 2010