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

Myelodysplastic Syndrome Clinical Trial

Official title:

Follow up Protocol to the Open Label Phase I/II Study OPN-305-106: 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 Third-line Lower (Low and Intermediate-1) Risk Myelodysplastic Syndrome (MDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337451
• Other study ID #: OPN-305-110
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 27, 2018
• Est. completion date: January 10, 2019

Study information

• Verified date: January 2019
• Source: Opsona Therapeutics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• OPN-305
Patients will receive study drug every 4 weeks

Locations

Country	Name	City	State
United States	Research Site	Houston	Texas

Sponsors (5)

Lead Sponsor	Collaborator
Opsona Therapeutics Ltd.	H. Lee Moffitt Cancer Center and Research Institute, M.D. Anderson Cancer Center, Montefiore Medical Center, New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and types of Serious Adverse events		monthly through study completion, an average of 18 months
Primary	monitor ongoing efficacy responses	To monitor ongoing efficacy responses defined as "transfusion independence". Transfusion independence is defined as 56 consecutive days where no RBC transfusions are given	monthly through study completion, an average of 18 months