Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome
- Registration Number
- NCT03337451
- Lead Sponsor
- Opsona Therapeutics Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OPN-305 OPN-305 -
- Primary Outcome Measures
Name Time Method Incidence and types of Serious Adverse events monthly through study completion, an average of 18 months monitor ongoing efficacy responses monthly through study completion, an average of 18 months To monitor ongoing efficacy responses defined as "transfusion independence". Transfusion independence is defined as 56 consecutive days where no RBC transfusions are given
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇺🇸Houston, Texas, United States