Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2019-01-10
• Target enrollment: 0
• Participant gender: All

Summary

This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy treatment or combination treatment with azacitidine after completion of the dose confirming, dose expansion and HMA naïve parts of the main study OPN-305-106.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Opsona Therapeutics Ltd.
• Collaborators: H. Lee Moffitt Cancer Center and Research Institute; M.D. Anderson Cancer Center; Montefiore Medical Center; New York Presbyterian Hospital

Criteria

Inclusion Criteria:

• Completion of the OPN-305-106 study

• Principal Investigator adjudicated efficacy response defined as either transfusion independence", "stable disease", "minor HI-E response" or "major HI-E response" and in the opinion of the Principal Investigator the patient may benefit from continued treatment with OPN-305 monotherapy or combination treatment with azacitidine.

• Provide written informed consent for the follow up protocol.

Exclusion Criteria:

• Refusal to provide written informed consent

• Withdrawal from the OPN-305-106 study prior to the final EOT visit

• Plan to be included into another interventional investigational study.

• Progression of disease