A phase I/II study of the efficacy and safety of an intensified schedule of Azacitidine (Vidaza®) in intermediate-2 and high risk MDS patients - GFM-Aza intensif

Overview

No summary available.

Registry

who.int

Start Date

May 18, 2010

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•MDS defined according to WHO classification (also including RAEB\-T according to
•FAB classification)(see appendix 1\) with an intermediate\-2 or high risk MDS IPSS
•score (see appendix 1\).
•Age \= 18 years and \<70 years.
•Must understand and voluntarily sign an informed consent form.
•Must be able to adhere to the study visit schedule and other protocol requirements.
•Patients must have ECOG performance status (PS) of 0 – 2, and no major
•comorbidities preventing administration of an intensified regimen of azacitidine.
•Women of child\-bearing potential (i.e., women who are pre\-menopausal or not
•surgically sterile) must:

•Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
•Pregnant and lactating patients are excluded because the effects of azacitidine on a
•foetus or breast\-fed child are unknown
•Uncontrolled intercurrent illness including, but not limited to uncontrolled infection,
•symptomatic congestive heart failure (NYHA \> II), cardiac arrhythmia, or psychiatric
•illness/social situations that would limit compliance with study requirements.
•Patients receiving any other standard or investigational cytotoxic treatment for their
•hematologic malignancy in the last 8 weeks.
•Any medical condition which in the opinion of the investigator places the patient at an
•unacceptably high risk for toxicities of an intensified regimen of azacitidine.