ATRA plus ATO versus ATRA plus Chemoterapy

Project objectives

The primary objective of the study is to compare event-free survival in the two arms.
The secondary objectives are:

• Compare CR, OS and CIR in the two arms

• Compare the toxicity profiles in the two arms

• Compare the kinetics of minimal residual disease in the two arms

• Compare the length of hospitalization in the two arms

STUDY DESIGN: Phase three randomized open-label multicenter study.

Start and end date

19/03/2008 - 20/06/2011

Project Manager

Prof. Giuseppe Avvisati

Coordinating institution of the project

• University of Rome "La Sapienza"

• GIMEMA Foundation

Other Institutions involved

Institutions belonging to the Italian Group of Adult Hematological Diseases (GIMEMA)

Funding source(s).

SPONSOR OF THE GIMEMA FOUNDATION STUDY