Status:
COMPLETED
Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome
Lead Sponsor:
Opsona Therapeutics Ltd.
Collaborating Sponsors:
M.D. Anderson Cancer Center
Montefiore Medical Center
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03337451
Start Date
February 27 2018
End Date
January 10 2019
Last Update
January 28 2019
Active Locations (1)
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1
Research Site
Houston, Texas, United States, 77030