A prospective, open label Phase I/II study to assess the safety and efficacy of cycles of intravenously infused doses of OPN-305 in second-line and first-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS)
This is a 3 part study. This consent form is for Parts 1 and 2 only. The goal of Part 1 of this clinical research study was to find the dose of OPN-305 that researchers think will work best in the treatment of patients with low or intermediate-1 risk MDS who were previously treated with azacitidine or decitabine. Researchers also want to learn how often OPN-305 should be given. This part of the study is now closed. The goal of Part 2 of this study, is to learn if the dose found in Part 1 can help to control low and/or intermediate-1 risk MDS when given alone or with azacitidine in patients who were previously treated with azacitidine or decitabine. The goal of Part 3 of this study, is to learn if the dose found in Part 1 or a higher dosecan help to control low and/or intermediate-1 risk MDS when given alone or with azacitidine in patients who have not been previously treated with azacitidine or decitabine. The safety and efficacy of this drug will be studied in all parts of the study.
Disease Group: Leukemia
Treatment Agent: OPN-305
Treatment Location: Both at MDACC & and Other Sites
Sponsor: Opsona Therapeutics Ltd.
IRB Review and Approval Date: 12/15/2014
Recruitment Status: Open
Projected Accrual: 85
Information and next steps
Phase I/Phase II
For general questions about clinical trials: