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Completed

NCT Number: NCT03337451

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

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.

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Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPN-305

Drug

Patients will receive study drug every 4 weeks

Primary outcomes

  1. Incidence and types of Serious Adverse events

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

  2. monitor ongoing efficacy responses

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

    To monitor ongoing efficacy responses defined as "transfusion independence". Transfusion independence is defined as 56 consecutive days where no RBC transfusions are given

Sponsors and collaborators

Lead sponsor

Opsona Therapeutics Ltd.

Industry

Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute
  • M.D. Anderson Cancer Center
  • Montefiore Medical Center
  • New York Presbyterian Hospital

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2017
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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