NCT04989335

Bisantrene Combination for Resistant AML

An Open-label, Phase II, Two-stage, Study of Bisantrene(Xantrene) in Combination With Fludarabine and Clofarabine as Salvage Therapy for Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelogenous Leukemia, Acute

Interventions

Type	Name	Description
DRUG	Bisantrene	Combined escalated dose chemotherapy
DRUG	Fludarabine	Combined escalated dose chemotherapy
DRUG	Clofarabine	Combined escalated dose chemotherapy

Timeline

• Start date: 2021-08-02
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2021-08-04
• Last updated: 2023-11-28

Locations

1 site across 1 country: Israel