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

Completed · Phase 1/Phase 2

Conditions studied: Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID

NCT03337451

Run by

Opsona Therapeutics Ltd.

People needed

14

Starts

2018-02-27

Expected to finish

2019-01-10

Last updated by the study team

2019-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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