Not yet recruitingRare disease

Study on the Safety and Effectiveness of Peginterferon Alfa-2a and Ruxolitinib for Newly Diagnosed Polycythemia Vera Patients

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What is this trial about?

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

This clinical trial is focused on studying a condition called Polycythemia Vera, a type of blood cancer that causes the body to produce too many red blood cells. The study is testing a combination of two treatments: Peginterferon Alfa-2a, which is given as an injection under the skin, and Ruxolitinib, also known by its code name INCB018424, which is taken as a tablet by mouth. The purpose of the study is to evaluate the safety of this combination therapy over a period of 24 months.

Participants in the study will receive both medications and will be monitored for any side effects or adverse reactions. The study will also look at how well the treatment works in controlling the disease by measuring various health indicators at different times throughout the study. These indicators include the levels of red blood cells, white blood cells, and platelets, as well as any symptoms related to the disease.

The trial aims to provide valuable information on the safety and effectiveness of using Peginterferon Alfa-2a and Ruxolitinib together in treating newly diagnosed patients with Polycythemia Vera. Participants will be closely monitored by healthcare professionals to ensure their well-being throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of polycythemia vera, and a negative test for tuberculosis.
Additional criteria such as elevated blood counts or symptoms like weight loss, night sweats, or itching may be evaluated.
Step 2
Treatment initiation
The treatment involves a combination of two medications: peginterferon alfa-2a and ruxolitinib.
Peginterferon alfa-2a is administered subcutaneously, which means it is injected under the skin.
Ruxolitinib is taken orally in the form of 5 mg tablets.
Step 3
Treatment schedule
The treatment is planned to continue for a duration of 24 months.
Regular monitoring is conducted to assess the safety and effectiveness of the treatment.
Step 4
Monitoring and assessments
Throughout the trial, regular assessments are performed to monitor the safety profile, including any adverse events.
Efficacy is evaluated by measuring blood counts and other health indicators at specified intervals: 3, 6, 8, 9, 12, 18, and 24 months.
Step 5
Completion of trial
At the end of the 24-month period, a final assessment is conducted to evaluate the overall safety and efficacy of the treatment.
The study aims to determine the proportion of patients achieving complete hematological remission and other health outcomes.

Who can join the trial?

12 criteria

The participant must be **18 years or older**.
The participant must have a **confirmed diagnosis of polycythemia vera (PV)**, which is a condition where the body makes too many red blood cells, according to the WHO 2016 criteria.
The participant must have a **negative test for active or latent tuberculosis** (a serious lung infection) from within the last month.
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The participant must have **biochemical evidence of active disease**, which means:
- High levels of red blood cells or hematocrit (the proportion of blood made up of red blood cells), or
- A white blood cell count greater than 10 billion per liter, or
- A platelet count greater than 400 billion per liter.
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  The participant may have **hypermetabolic symptoms**, which include:
  - Weight loss of more than 10% within 6 months,
  - Night sweats, or
  - A fever higher than 38°C for more than 2 weeks without signs of infection.
  - The participant may experience **pruritus**, which is a severe itching sensation.
  - The participant may have **symptomatic splenomegaly**, which means an enlarged spleen causing symptoms.
  - The participant may have a **history of previous thrombosis**, which refers to blood clots.

Who cannot join the trial?

4 criteria

Patients who do not have **polycythemia**, a condition where the body makes too many red blood cells, cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to a clinical trial group that is not included in this study cannot participate.
Patients who are part of a vulnerable population, meaning they might need special protection, cannot participate.

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Region Sjaelland
Holbæk, Denmark

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Investigated drugs

Interferon-Alpha2a
is a medication used to help the body's immune system fight against diseases. In this trial, it is being used to treat patients who have been newly diagnosed with polycythemia vera, a type of blood cancer. The goal is to see how safe and effective this medication is when used in combination with another treatment.
Ruxolitinib
is a medication that helps reduce the number of blood cells produced by the body. It is used in this trial to treat polycythemia vera by controlling the overproduction of blood cells. The study aims to evaluate the safety and effectiveness of using this medication together with Interferon-Alpha2a.

What is already known about the treatment

Interferon-Alpha2a
This medication is administered via injection and is currently being studied for its safety and effectiveness in treating polycythemia vera, a condition characterized by an overproduction of red blood cells. It is well-documented in medical literature as a treatment option for various blood disorders. The main therapeutic indication for Interferon-Alpha2a in this trial is to manage polycythemia vera. At the molecular level, it works by modulating the immune system and inhibiting the proliferation of abnormal blood cells. It is classified as an immunomodulatory agent.
Ruxolitinib
This medication is taken orally and is also being evaluated for its safety and efficacy in patients with polycythemia vera. It is widely recognized in medical literature as a treatment for certain blood cancers and disorders. The primary therapeutic use of Ruxolitinib in this context is to control the symptoms and progression of polycythemia vera. Its mechanism of action involves inhibiting specific enzymes known as Janus kinases, which play a role in the signaling pathways that lead to the overproduction of blood cells. Ruxolitinib is classified as a Janus kinase inhibitor.

Investigated diseases

Polycythemia Vera – Polycythemia Vera is a rare blood disorder characterized by the overproduction of red blood cells in the bone marrow. This excess of red blood cells thickens the blood, slowing its flow and potentially leading to complications such as blood clots. As the disease progresses, individuals may experience symptoms like headaches, dizziness, and a ruddy complexion. Over time, the increased blood cell production can also affect white blood cells and platelets, further complicating the condition. The disease is often associated with a mutation in the JAK2 gene, which plays a role in blood cell production. Regular monitoring and management are essential to address the symptoms and prevent complications.