Velcaflagida in Relapsed or Refractary Acute Myeloid Leukemia
Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
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.