Velcaflagida in Relapsed or Refractary Acute Myeloid Leukemia

Summary

The primary aim of this study is: • To analyze the efficacy (in order to evaluate the response) of a sequential treatment scheme of Bortezomib in combination with Fludarabine,Cytarabine and Idarubicin continued with Bortezomib monotherapy for patients with relapsed or refractory AML ≥18 years old. The safety aim of this study is: • To evaluate the safety and tolerance of the sequential treatment scheme proposed with Bortezomib combined with Fludarabine, Cytarabine and Idarubicin and in monotherapy, measured on clinical toxicities and laboratory incidences. The biological aim of this study is: • To evaluate the Minimal Residual Disease (MRD)impact that will be monitored by multiparametric flow cytometry carried out at different moments during the treatment.

Timeline

Start

2008-04

Primary completion

2013-01

Completion

2013-02

Drugs

Indications