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.
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
Categories
Completion Date
Completion Date Type
Actual
Conditions
Myelodysplastic Syndrome
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
* 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
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03337451
Org Class
Industry
Org Full Name
Opsona Therapeutics Ltd.
Org Study Id
OPN-305-110
Overall Status
Completed
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome Measure
Incidence and types of Serious Adverse events
Outcome Time Frame
monthly through study completion, an average of 18 months
Outcome Description
To monitor ongoing efficacy responses defined as "transfusion independence". Transfusion independence is defined as 56 consecutive days where no RBC transfusions are given
Outcome Measure
monitor ongoing efficacy responses
Outcome Time Frame
monthly through study completion, an average of 18 months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Aditi Shastri
Investigator Email
ASHASTRI@montefiore.org
Investigator Phone
718-920-4826
Categories Mesh Debug
Blood & Bone Marrow Cancers --- MYELODYSPLASTIC SYNDROMES
Blood & Bone Marrow Cancers --- BONE MARROW DISEASES
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
MeSH Terms
MYELODYSPLASTIC SYNDROMES
BONE MARROW DISEASES
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
TOMARALIMAB