Overview

Azacytidine (Vidaza®) Versus Fludarabine and Cytarabine (Fluga Scheme) in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

Status:
Completed

Trial end date:
2019-10-28

Target enrollment:

Participant gender:

Summary

The hypothesis is that the replacement of the standard fludarabine and cytarabine based therapy by azacytidine could result in an improvement of RFS and OS rates in the experimental arm. To fulfill the medical needs in such frail and elderly population, improvements in terms of atileukemic efficacy in the azacytidine experimental arm should be attained without increasing the therapy-related toxicity or decreasing the patients QoL.

Phase:

Phase 3

Details

Lead Sponsor:

PETHEMA Foundation

Collaborator:

Dynamic Solutions

Treatments:

Azacitidine
Cytarabine
Fludarabine
Fludarabine phosphate
Lenograstim
Vidarabine