Understanding how interferon works for treating myeloproliferative neoplasms

Mechanism of Action of Interferon in the Treatment of Myeloproliferative Neoplasms

This study is trying to see how a treatment called pegylated interferon works for people with certain blood cancers to understand why some patients respond better than others.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Government)
• Locations: 1 site (Villejuif, Île-de-France Region)
• Trial ID: NCT05850273 on ClinicalTrials.gov

What this trial studies

This observational study focuses on classical BCR-ABL-negative myeloproliferative neoplasms (MPN) such as Polycythemia Vera, Essential Thrombocythemia, and Primary Myelofibrosis. It aims to investigate the mechanism of action of pegylated interferon alpha (Peg-IFNα2a) in patients diagnosed with MPN, particularly those with JAK2V617F and CALR mutations. The study will involve collecting blood samples from patients who are either newly diagnosed or currently undergoing treatment, to analyze their responses to the therapy. The goal is to better understand the variability in treatment responses and identify factors influencing efficacy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of myeloproliferative neoplasms who are being treated or are newly diagnosed.

Not a fit: Patients who do not have a diagnosis of myeloproliferative neoplasms or those who are not eligible for treatment with pegylated interferon will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment strategies for patients with myeloproliferative neoplasms.

How similar studies have performed: While the use of interferon in treating MPN has been explored, this study aims to provide deeper insights into its mechanisms, making it a novel approach.

Eligibility criteria

Inclusion Criteria:

1. Adult male or female 18 years of age or older
2. Diagnosis of MPN has been previously established by the referring physician and that physician will have decided to treat with pegylated IFN. Patients will be treated or untreated at the time of inclusion and may be newly diagnosed patients.
3. These patients will be affiliated with or benefit from a social security plan
4. For all these patients an additional 20-40 mL will be collected except for some PV patients who are treated conventionally by phlebotomy. In this case, we will collect blood bags from these patients. The volumes vary between 300 and 450 mL of blood depending on the weight and size of the patients.
5. We will also include in this protocol any patient whose MPN, either PV, TE or MF, will have progressed to acute leukemia (AL) during treatment. These will be patients with AP of MPN (MPN can also progress to acute myeloid leukemia (AML) by acute transformation (AT) of MPN).
6. Patient with signed informed consent

Exclusion Criteria:

1. The non-inclusion criterion concerns the anemia that some MF patients may suffer from. Therefore, patients with anemia (Hb\<10g) or transfusion dependency (≥ 1 packed red blood cell per month) at the time of the referral monitoring visit are not included in the research.
2. Persons under court protection, guardianship or curatorship

Where this trial is running

Villejuif, Île-de-France Region

• Inserm U1287 — Villejuif, Île-de-France Region, France (Recruiting)

Study contacts

• Principal investigator: Florence Pasquier, MD,PhD — [e-mail]
• Study coordinator: isabelle Plo, PhD

Conditions Myeloproliferative Neoplasm; interferon alpha; Hematopoietic stem cell; mechanism of action