You may be eligible to join EXCEED ET, a Phase 2b clinical research study in the US and Canada that evaluates the potential of a new, investigational ET therapy to control the number of platelets and white blood cells in the blood.
Essential thrombocythemia (ET) is a rare blood cancer that is characterized by several genetic mutations that lead to an increase in blood counts (the number of platelets and, in some cases, white blood cells). This increase in blood counts can cause blood clots and vascular complications. Some people with ET have no symptoms while others may develop many health problems. ET may progress to myelofibrosis or secondary acute myeloid leukemia.
Symptoms can include the following:
ET can also cause more serious health problems because of the increased risk of blood clots. These can include strokes and heart attacks, although these are rare events.
The goal of treatments for ET is to reduce the number of platelets and, in some cases, white blood cells in the blood to help reduce the symptoms and potential health risks.
This study is investigating a specific type of interferon alfa, ropeginterferon alfa-2b-njft, which reduces the number of platelets and white blood cells in the blood.
Patient participation in clinical research studies is important in helping us learn more about potential new treatments for the community.
The EXCEED ET study is for adults who have been diagnosed with ET who:
Have not received any treatment for their ET in the past
Have received treatments such as hydroxyurea or anagrelide for their ET, but they may have stopped working or had unbearable side effects
The purpose of this study is to evaluate the effectiveness and safety of ropeginterferon alfa-2b-njft in adult patients with ET.
The main study will last approximately 15 months, including a screening period, titration period, and a core treatment period. After completion of the core study period, study participants who benefitted from treatment will continue on to an extension period of the study. This portion of the study will allow investigators to evaluate the effectiveness of ropeginterferon alfa-2b-njft in the long term.
Did your doctor diagnose your ET because of elevated blood counts (platelets and, in some cases, white blood cells), mutational testing (JAK2 V617F, CALR, or MPL), and bone marrow biopsy/evaluation?
Have you had any prior treatment with an interferon?
Have you had any prior treatment with ruxolitinib?
18 years of age or older
Diagnosed with ET according to criteria, including elevated platelets, the presence of a genetic mutation (eg, JAK2 V617F, CALR, or MPL), and a bone marrow biopsy
Treated with hydroxyurea and/or anagrelide for their ET, but these may have stopped working or had unbearable side effects
Never received interferon alfa and/or ruxolitinib for their ET in the past
Study participants will need to meet additional eligibility criteria to be accepted to enroll in the study.
If you agree to participate in the clinical study, you will visit the study clinic and undergo a series of assessments to find out if you meet all the study requirements before beginning participation. If you meet all the requirements, you can then begin the study treatment period. Once you have completed the main study treatment period (up to 15 months), you may continue on to the extension period of the study.
Up to 4 weeks
Up to 2 years*
Up to 4 weeks after last treatment visit
The length of time for which you receive treatment will vary depending on how you respond to the study drug.
For more information about the EXCEED ET clinical study, please visit ClinicalTrials.gov (trial identifier: NCT05482971).