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

Opsona Therapeutics Ltd.14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelodysplastic Syndrome

Interventions

OPN-305DRUG

Patients will receive study drug every 4 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Houston, Texas, United States

Outcomes

Primary Outcomes

Incidence and types of Serious Adverse events

Time frame: monthly through study completion, an average of 18 months

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

Time frame: monthly through study completion, an average of 18 months

Data from ClinicalTrials.gov

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