Study on Hydroxycarbamide Resistance in Patients with Polycythemia Vera Identified by AI Predictors

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What is this study about?

This clinical trial is focused on studying polycythemia vera, a condition where the body produces too many red blood cells, which can lead to complications like blood clots. The study will use a medication called hydroxyurea, also known as hydroxycarbamide, which is commonly used to manage this condition. The purpose of the study is to evaluate how patients with polycythemia vera respond to hydroxyurea, particularly looking at resistance or intolerance to the medication.

Participants in the study will begin their regular treatment with hydroxyurea, and researchers will monitor them over a period of up to 15 months. The study will use advanced techniques, including artificial intelligence, to identify patients who might be resistant to hydroxyurea before they start treatment. This will help in understanding which patients are more likely to benefit from the medication and who might need alternative treatments.

Throughout the study, researchers will observe how many patients develop resistance or intolerance to hydroxyurea within the first 6 to 9 months and over the entire 15-month period. They will also look at the reasons why some patients might need to switch to different therapies and the timing of these changes. This information will be valuable in improving treatment strategies for polycythemia vera in the future.

1 joining the study

Upon joining the study, ensure that a signed informed consent is obtained. This confirms your understanding and agreement to participate in the clinical trial.

Eligibility criteria include being at least 18 years old, having a confirmed diagnosis of polycythemia vera, and meeting specific health conditions. A negative pregnancy test is required for female participants of childbearing potential.

2 start of treatment

Begin treatment with hydroxycarbamide, taken orally. The dosage and frequency will be determined by the study team based on your specific needs.

The main objective is to evaluate resistance or intolerance to hydroxycarbamide in patients with polycythemia vera.

3 monitoring period

Regular monitoring will occur to assess your response to the treatment. This includes checking for any signs of resistance or intolerance to hydroxycarbamide.

The primary endpoint is to determine the proportion of patients showing resistance or intolerance within 6-9 months of starting treatment.

4 follow-up assessments

Follow-up assessments will continue for a maximum period of 15 months. These assessments will help identify any changes in your condition and the effectiveness of the treatment.

Secondary endpoints include evaluating the proportion of patients developing resistance or intolerance at any time during the treatment period.

5 completion of study

Upon completion of the study, a final assessment will be conducted to summarize your overall response to the treatment.

The study aims to conclude by October 31, 2025, with all data collected and analyzed to understand the treatment’s impact.

Who Can Join the Study?

  • Signed informed consent must be obtained before participating in the study. This means you agree to join the study after understanding all the details.
  • Patients must be 18 years or older.
  • Must have a confirmed diagnosis of Polycythemia vera according to specific medical guidelines.
  • Must have an ECOG score of 2 or less. The ECOG score is a way to measure how well you can perform daily activities. A score of 2 means you are up and about more than half of the day but may not be able to work.
  • No previous treatment with drugs that reduce blood cell production.
  • No blood removal (phlebotomy) in the last 14 days.
  • Must be eligible for HU (Hydroxyurea) treatment. This includes:
    • High-risk: Age 60 years or older and/or a history of blood clots.
    • Low-risk: Showing at least one of the following:
      • Signs of disease getting worse (myeloproliferation).
      • Increasing risk of blood clots and bleeding.
  • Female participants who can have children must have a negative pregnancy test within 72 hours before receiving the first dose of the study treatment.

Who Cannot Join the Study?

  • Patients who do not have Polycythemia vera cannot participate. Polycythemia vera is a condition where the body makes too many red blood cells.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who do not meet the HU-resistance predictors cannot participate. HU-resistance refers to how the body responds to a specific treatment called hydroxyurea (HU).
  • Patients who are not able to start regular HU-treatment cannot participate.
  • Patients who are part of a vulnerable population may not be eligible. Vulnerable populations include groups who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Gemeinschaftspraxis Haematologie Onkologie Dresden Germany
Onkologie Erding Erding Germany

Other Sites

Site Name City Country Status
Haematologie-Onkologie im Zentrum MVZ GmbH Augsburg Germany
Onkodok GmbH Guetersloh Germany
Onkologisches Zentrum Donauwörth Donauwörth Germany
Carl-von-Basedow-Klinikum Saalekreis gGmbH Merseburg Germany
Medizinische Studiengesellschaft Nord-West GmbH Westerstede Germany
Gemeinschaftspraxis für Hämatologie und Onkologie Erfurt Germany
Kreiskrankenhaus Torgau Johann Kentmann gGmbH Torgau Germany
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts Mutlangen Germany
GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH Dortmund Germany
Onkologische Schwerpunktpraxis Heidelberg Heidelberg Germany
MVZ-Onkologie Velbert GbR Velbert Germany
Barmherzige Brueder gemeinnuetzige Traeger GmbH Straubing Germany
Medizinische Statistik Saarbrücken GbR Saarbrücken Germany
Gemeinschaftspraxis Für Hämatologie And Onkologie Langen Germany
Gemeinschaftspraxis Dr Med Regina Moeller Dr Med Tabea Appel Anett Krziwanie Halle (Saale) Germany
Ontpixlhwfjp Swmvidjsbzbluczga Dxs Abwny Kronach Germany
Oqipgdr Mvfsp Gzl Moers Germany
Mva Zgwifel fgxp avjwoepka Ohmoioyvt Gcsc Tuebingen Germany
Olpbaejutrmvf Vjwgqvgncimxpiwkzo Fnfwtfltsgzmbu Hlmcqptrhbqb Ogenmtyit uqz Pbsxuwxpczcprgon Berlin Germany
Pbcgym Dvrue mzje Bndgmce ucw Sakant Kiel Germany
Bnrraffwsb Hwomfhfi Lxnhij glgib Lingen (Ems) Germany
Mnr Owatdglxrsqw Kktuaqayggp Hvyr Ggj Goslar Germany
Imfu Ibumhtsnfpycpr Onvboaalnqay Gqlxnafxuvcvmondujp Gera Germany
Miv Whnu Gpqr Wjwsnyru Hhiqkpgqlgcslzcxmpqfl Würselen Germany
Pryxjf Dcn mdsp Jvvk Uwjis Naunhof Germany
Ms Sviwbpirrnpevfepcvk Gyv Aachen Germany
Lymdatcj Obutxeydtqfr Sbmobwxmvfbmkjqxq Luebeck Germany
Skxfibfcxtlmop aq Rkgfrdbpoc Hanover Germany
Mhi fuag Hvkszutobvfr usp Omkotsvzc Khwwu Aj Shwiasbymlg Gcky Cologne Germany
Jvblunxjhu Gtgl Jlxfxhjaahewhfbfdxgqgn Bonn Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.05.2023

Trial locations

Investigated drugs:

Hydroxyurea is a medication used in this clinical trial. It is commonly used to treat a condition called polycythemia vera, which is a blood disorder where the body makes too many red blood cells. This can lead to problems like blood clots. Hydroxyurea works by slowing down the production of these extra blood cells, helping to keep the blood thinner and reducing the risk of complications. In this study, the focus is on understanding how some patients might not respond well to Hydroxyurea, which is referred to as resistance or intolerance to the medication.

Investigated diseases:

Polycythemia vera – Polycythemia vera is a blood disorder characterized by the overproduction of red blood cells in the bone marrow. This increase in red blood cells causes the blood to thicken, which can slow down blood flow and lead to complications. As the disease progresses, individuals may experience symptoms such as headaches, dizziness, and a feeling of fullness in the abdomen due to an enlarged spleen. Over time, the increased blood cell production can also lead to elevated levels of white blood cells and platelets. The condition may cause itching, especially after a warm shower, and a ruddy complexion. If left unchecked, polycythemia vera can lead to more serious issues such as blood clots.

Trial ID:
2022-502338-20-00
Protocol code:
CINC424BDE15
Trial Phase:
Therapeutic confirmatory (Phase III)

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