Randomized phase III study to compare arsenic trioxide (ATO) treatment in combination with retinoic acid (ATRA versus ATRA plus anthracycline-based chemotherapy for patients #3BB6395)
Project Objectives
The primary objective of the study is to compare event-free survival between the two groups.
Secondary objectives are to compare between the two groups:
- CR, OS and CIR rates
- The toxicity profile
- The kinetics of minimal residual disease
- The duration of hospitalization
Study Design: Open label, randomized, multicenter phase III trial
Start/End Date
March 19, 2008 - June 20, 2011
Principal Investigator
Prof. Giuseppe Avvisati
Host Institution
- Sapienza Università di Roma - Italy
- Fondazione GIMEMA
Other Institutions involved
Institutions included in the “Gruppo Italiano Malattie Ematologiche dell’Adulto (GIMEMA)”
Source of funding
Fondazione GIMEMA