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

Primary Purpose

Myelodysplastic Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
OPN-305
Sponsored by
Opsona Therapeutics Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OPN-305

Arm Description

Outcomes

Primary Outcome Measures

Incidence and types of Serious Adverse events
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

Secondary Outcome Measures

Full Information

First Posted
October 18, 2017
Last Updated
January 24, 2019
Sponsor
Opsona Therapeutics Ltd.
Collaborators
M.D. Anderson Cancer Center, Montefiore Medical Center, H. Lee Moffitt Cancer Center and Research Institute, New York Presbyterian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03337451
Brief Title
Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
January 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Opsona Therapeutics Ltd.
Collaborators
M.D. Anderson Cancer Center, Montefiore Medical Center, H. Lee Moffitt Cancer Center and Research Institute, New York Presbyterian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPN-305
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OPN-305
Intervention Description
Patients will receive study drug every 4 weeks
Primary Outcome Measure Information:
Title
Incidence and types of Serious Adverse events
Time Frame
monthly through study completion, an average of 18 months
Title
monitor ongoing efficacy responses
Description
To monitor ongoing efficacy responses defined as "transfusion independence". Transfusion independence is defined as 56 consecutive days where no RBC transfusions are given
Time Frame
monthly through study completion, an average of 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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