Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Study aims to predict drug failure in rare blood cancer

NCT ID NCT05853458

Knowledge-focused Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study looked at whether two simple blood test results—hemoglobin and red blood cell distribution width—could predict if a person with polycythemia vera would stop responding to the drug hydroxyurea. Researchers planned to follow 76 adults starting hydroxyurea for the first time. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

76 people

The number who actually took part.

Started

Jul 2023

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion criteria 1. Signed informed consent must be obtained prior to participation in the study 2. Patients ≥18 years 3. Confirmed diagnosis of Polycythemia vera (according to WHO 2008, 2016, or 2022 criteria) (Tefferi and Vardiman 2008, Arber et al 2016, Khoury et al 2022) 4. Eastern Cooperative Oncology Group (ECOG) ≤ 2 5. No previous pharmacologic cytoreductive therapy (including investigational drugs) 6. No phlebotomy in last 14 days 7. HU-eligible * High-risk: age ≥ 60 years and/or prior history of thrombosis * Low-risk: showing at least one of the defined criteria * Signs of disease progression (myeloproliferation): * Increase in spleen size or symptomatic splenomegaly * Platelet increase to \> 1,000,000/µl * WBC increase to \> 15,000/µl or higher * Frequent (\> 10 per year) or increasing frequency of phlebotomies * Increasing risk of thromboembolism and bleeding: * New thromboembolism and/or hemorrhagic complications * Microcirculation disorders despite acetyl salicylic acid (ASA) 2x 100 mg/day * Restricted feasibility or intolerance of phlebotomies * Symptomatic iron deficiency * Uncontrolled increase in hematocrit * Severe or distressing disease-related symptoms 8. Female participants of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study treatment. Key Exclusion criteria 1. Patients with post-polycythemia vera myelofibrosis (post-PV MF) or accelerated phase/ blast phase myeloproliferative neoplasm acute myeloid leukemia (AP/BP-MPN AML). 2. Patients with a contraindication to HU according to the SmPC (severe bone marrow depression, leukopenia (\< 2.5 x 109 leukocytes/l), thrombocytopenia (\< 100 x 109 platelets/L), severe anemia (\< 10 g/dL HGB). 3. Patients with rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption in their past medical history. 4. Active uncontrolled infection that is considered by the Investigator as a reason for exclusion. 5. Active malignancies (except for carcinoma in situ; prostate cancer and breast cancer in remission and - where necessary - ongoing hormonal therapy). 6. Inadequate renal function as demonstrated by Modification of Diet in Renal Disease estimate glomerular filtration rate (MDRDeGFR) \< 30 mL/min/1.73m2 or on dialysis. 7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test. 8. Sexually active males unwilling to use a condom during intercourse while taking study treatment and for at least 3 months after stopping study treatment. 9. HIV patients treated with nucleoside reverse transcriptase inhibitors like didanosine and stavudine. Other inclusion/exclusion criteria may apply

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Polycythemia vera are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acquired polycythemia vera

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Polycythemia vera

Contacts and locations

Locations

  • Novartis Investigative Site

    Heidelberg, Baden-Wurttemberg, 69115, Germany

  • Novartis Investigative Site

    Kronach, Bavaria, 96317, Germany

  • Novartis Investigative Site

    Straubing, Bavaria, 94315, Germany

  • Novartis Investigative Site

    Langen, Hesse, 63225, Germany

  • Novartis Investigative Site

    Lingen, Lower Saxony, 49808, Germany

  • Novartis Investigative Site

    Aachen, North Rhine-Westphalia, 52064, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50674, Germany

  • Novartis Investigative Site

    Dortmund, North Rhine-Westphalia, 44309, Germany

  • Novartis Investigative Site

    Velbert, North Rhine-Westphalia, 42551, Germany

  • Novartis Investigative Site

    Saarbrücken, Saarland, 66113, Germany

  • Novartis Investigative Site

    Merseburg, Saxony-Anhalt, 06217, Germany

  • Novartis Investigative Site

    Berlin, 10407, Germany

  • Novartis Investigative Site

    Donauwörth, 86609, Germany

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Erding, 85435, Germany

  • Novartis Investigative Site

    Gütersloh, 33332, Germany

  • Novartis Investigative Site

    Hanover, 30161, Germany

  • Novartis Investigative Site

    Kiel, 24105, Germany

  • Novartis Investigative Site

    Mutlangen, 73557, Germany

  • Novartis Investigative Site

    Naunhof, 04683, Germany

  • Novartis Investigative Site

    Würselen, 52146, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.