Observatory of Patients With MyeloProliferative Neoplasm Treated With Anti-inflammatory Immunotherapy (OPIUM)

The study will collect cases of MPN patients who also benefit from an anti-inflammatory immunotherapy for another disease. Efficacy and tolerability of the drug will be assessed in this population.

Study Overview

• Status: Active, not recruiting
• Conditions: Myeloproliferative Neoplasm; Inflammatory Disease

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

MyeloProliferative Neoplasm patients followed in one of the centres participating to the FIM (French Intergroup- MPN) group

Description

Inclusion Criteria:

• MyeloProliferative Neoplasm diagnosis
• receiving or having received an immunotherapy targeting IL-1, IL-6, IL-17, IL-23 or TNF

Exclusion Criteria:

• Unable to consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the anti-inflammatory immunotherapy	Depending on the indication of the anti-inflammatory treatment, clinical efficacy will be assessed clinically as number of patients reaching complete (total disappearance of initial symptoms- diarrhea, arthritis, fever, skin lesions), partial (improvement of symptoms, but not total disappearance) or absence of response (the treatment did not improve the symptoms). Clinical judgement will be according to the physician appreciation.	1 year
Tolerability of the anti-inflammatory immunotherapy	Tolerability will be assessed as the number of reported unexpected side effects attributed to the treatment as judged by the caring physician, including treatment discontinuation	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Neoplasms; Myeloproliferative Disorders
• Other Study ID Numbers: 29BRC24.0155 - OPIUM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No