21
Participants
Start Date
December 31, 2016
Primary Completion Date
June 30, 2020
Study Completion Date
June 30, 2020
Arsenic Trioxide Injectable Solution
"Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).~Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.~The study duration will be 2 years (12 months recruitment + 12 months follow-up)."
Lead Sponsor
Medsenic
INDUSTRY