Clinical Trials. gov identifier:
N° of patients expected by the study:
End of the enrollment
> 18 years old
Myelodysplasia object of the study:
all kind of myelodysplasia
Multicentric phase II study
Title of the study:
STUDY OF ASSOCIATION OF ARSENIC TRIOXIDE (ATO) AND ASCORBIC ACID IN MYELODYSPLASTIC SYNDROMES
Description of the study:
The study aims to study the use of arsenic trioxide in combination with ascorbic acid in the treatment of myelodysplasia.
This is an interventiona multicentric phase II study; the Sponsor was AISSM (Italian Association for the Study of Myelodysplastic Syndromes) then evolved in FISM
Were eligible patients with:
- Any type of myelodysplasia with high levels of EVI-1 transcripts and rearrangements of chromosome 3q26
- Myelodysplastic Sindrome without excess blasts ( non RAEB patients) with low or intermediate IPSS and where the primary treatment line has failed
- Non-RAEB patients with a high or intermediate IPSS score or RAEB patients (with any IPSS score) that can not be treated with conventional chemotherapy.
The last patient was enrolled at the end of 2008.