The primary objective of this study is to compare the survival of patients treated with elacytarabine with the survival of patients receiving the treatment(s) chosen by the investigator. The secondary objectives are to compare the response rates, duration of response, and safety profile of elacytarabine with the investigator's choice treatments.
Patients randomised to the investigators' choice group can receive either of the following treatments:
- High-dose cytarabine for up to six days
- MEC - mitoxantrone, etoposide and cytarabine
- FLAG or FLAG-IDA - fludarabine, cytarabine, G-CSF and idarubicin
- Low-dose cytarabine
- Azacytidine or decitabine
- Hydroxyurea
- Supportive care
The results from this study, if positive, will be used by Clavis Pharma to support regulatory filings in the USA, Canada, Australia and Europe.
There is currently no standard therapy available for these patients and life expectancy is very short. The key results from the Phase II study were:
- Median survival three times longer (5.3 months vs. 1.5 months)
- Remission rate significantly increased (18% vs 4.1%, p<0.0001)
- Short-term mortality of 13%, substantially lower than the reported 25% for historical controls.
The Chairman of the CLAVELA study's steering committee is Professor Francis J. Giles, Galway/DublinUniversity, Ireland. Other members of the steering committee are Professor Martin Tallman, Memorial Sloan-Kettering Cancer Center, New York, USA, Professor Hartmut Doehner, University of Ulm, Ulm, Germany and Professor Alan Burnett, Cardiff University, School of Medicine, Cardiff, UK
For more information see clinicaltrials.gov. For published articles and posters see section Publications.