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Anakinra for patients with myeloproliferative neoplasms resistant to cytoreductive therapy: a study to improve treatment response

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people with myeloproliferative neoplasms, a group of blood disorders in which the bone marrow produces too many blood cells. The medication being tested is anakinra, provided as a injection that blocks a protein called interleukin‑1, which can cause inflammation.

The purpose is to determine whether adding this drug lowers the level of a blood protein called calprotectin after three months compared with standard treatment alone. Participants will have blood samples taken and complete short questionnaires at the start of the study, at three months, and at six months, and they will record each dose taken in a simple diary. Safety will be monitored by checking for any side effects throughout the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    The patient attends the first study visit after enrollment. during this visit, blood samples are taken to measure serum calprotectin and other blood counts. questionnaires are completed to record symptom severity using a 10‑point visual analog scale for pruritus, fever, and night sweats. a patient diary is provided for daily recording of medication intake.

  2. Step 2

    Start anakinra therapy

    The patient begins subcutaneous injection of anakinra at a dose of 100 mg per injection. the injection is administered once daily for a period of three months. the medication is supplied in a pre‑filled syringe containing 100 mg/0.67 ml solution.

  3. Step 3

    Daily diary entry

    Each day, the patient records in the diary whether the injection was taken (yes/no). the diary also captures any adverse events or side effects experienced.

  4. Step 4

    3‑month evaluation

    After three months of treatment, the patient returns for a follow‑up visit. blood samples are drawn again to compare serum calprotectin levels with the baseline result. additional laboratory tests include hemoglobin, hematocrit, white blood cell count, and platelet count. the same symptom questionnaires and visual analog scale are completed. the patient diary is reviewed for adherence and adverse events.

  5. Step 5

    Continuation of observation

    The patient may continue to take the medication as directed until the six‑month visit, if required by the study protocol. daily diary entries continue during this period.

  6. Step 6

    6‑month evaluation

    At six months, the patient undergoes a final study visit. blood tests are repeated for the same parameters as earlier visits, including serum calprotectin. symptom severity is assessed again with the visual analog scale. quality of life is measured using the eortc qlq‑c30 questionnaire. additional laboratory analyses such as multiplex assay of inflammatory cytokines and genetic mutation quantification are performed.

Who can join the trial?

4 criteria

  • Have a confirmed diagnosis of a myeloproliferative neoplasm (MPN) such as polycythemia vera (PV), essential thrombocythemia (ET), or primary myelofibrosis (PMF) according to the World Health Organization (WHO) guidelines, which are the standard rules doctors use to identify these conditions.
  • Be receiving a steady dose of medication that lowers the production of blood cells, called cytoreductive therapy, for at least six months without changes.
  • Show either an incomplete blood‑test response based on the European LeukemiaNet (ELN) criteria (which are specific standards for evaluating blood disease treatment) and not rely on a bone‑marrow test, or have a complete blood‑test response but still have anemia (low red blood cells) if the condition is ET, or continue to experience general symptoms such as fever, night sweats, itchy skin (pruritus), or fatigue that scores more than 5 out of 10 on a simple pain‑scale called the visual analog scale (VAS).
  • Be an adult who is able to understand the study information and sign the informed consent form.

Who cannot join the trial?

11 criteria

  • Having infections that keep coming back or are not well controlled (an infection is when germs like bacteria or viruses cause illness).
  • Not understanding the questionnaires or being unable to attend follow‑up visits (the study needs you to fill out forms and come back for check‑ups).
  • Women who could become pregnant and are unwilling to use appropriate birth control (methods that prevent pregnancy).
  • Having a low platelet count (less than 100 G/L); platelets are blood cells that help stop bleeding.
  • Having a low neutrophil count (less than 1 G/L); neutrophils are a type of white blood cell that fights infection.
  • Being allergic (hypersensitivity) to the study drug, any of its inactive ingredients, or proteins made from the bacterium Escherichia coli (a common gut bacteria).
  • Taking other medicines that suppress the immune system (immunosuppressive therapy).
  • Refusing to take part in the study.
  • Being under legal protection such as guardianship or curatorship (someone else makes legal decisions for you).
  • Being unable to give consent (unable to agree to join the study).
  • Being pregnant or breastfeeding (breastfeeding means feeding a baby with breast milk).
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Investigated drugs

Kineret is a medication that blocks a protein called interleukin‑1, which can cause inflammation. It is given as a liquid that is injected under the skin. In this study, it is being tested to see if it can lower a blood marker of inflammation called calprotectin in people with certain blood cancers (myeloproliferative neoplasms) who are not responding well to their usual treatments.

What is already known about the treatment

Anakinra - This medication is supplied as a sterile solution for injection in a pre‑filled syringe, intended for subcutaneous use. It is an approved drug that is widely used and described in medical literature, primarily for rheumatoid arthritis and certain autoinflammatory conditions. Anakinra works by blocking the interleukin‑1 receptor, which stops the inflammatory signals that IL‑1 would normally trigger. It belongs to the class of interleukin‑1 receptor antagonists, a type of immunomodulating agent.

Investigated diseases

Myeloproliferative neoplasms - A group of disorders in which the bone marrow produces an excess of one or more types of blood cells. Over time, the number of red cells, white cells, or platelets may gradually increase. This excess can cause the blood to become thicker and may lead to an enlarged spleen. Symptoms often develop slowly and can include fatigue, itching, or night sweats. The condition may change slowly, with blood counts fluctuating and sometimes shifting toward a different type of blood cell over months or years.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523921-17-00Protocol code29BRC25.0416Estimated enrolment50 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest

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