Bisantrene Combination for Resistant AML

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.

Timeline

Start

2021-08-02

Primary completion

2024-12-01

Completion

2025-12-01

Drugs

Indications