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The Ruxo-BEAT Trial in Patients With High-risk Polycythemia Vera or High-risk Essential Thrombocythemia

Study acronym: Ruxo-BEAT
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Jun 5, 2025, no change to tracked fieldsv19-v20
  2. Site details revised at 1 of 23 sitesv18
  3. Enrollment target: estimated 380 to confirmed 207
    • Eligibility criteria revised
    • Study sites revised (23)
    v17
  4. Re-verified, no change to tracked fieldsv16
  5. Primary completion date: Dec 2022 to Dec 2027v15 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 24 to 23
    • Study completion date: Dec 2027 to Dec 2028
    • Eligibility criteria expanded, about 181 words
    • Secondary endpoints: 7 to 8
Show 13 earlier versionsHide 13 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 27 to 24
    v14
  2. Primary completion date: Dec 2020 to Dec 2022
    • Study completion date: Dec 2022 to Dec 2027
    • Site details revised at 2 of 27 sites
    v13
  3. Site contacts updated at 1 of 27 sitesv12
  4. Study sites: 24 to 27v11
  5. Study sites: 22 to 24v10
  6. Phase: Phase 3 to Phase 2v9 Show 4 more changesShow less
    • Study sites: 21 to 22
    • Study completion date: Dec 2020 to Dec 2022
    • Eligibility criteria expanded, about 12 words
    • Collaborator revised
  7. Site details revised at 5 of 21 sitesv8
  8. Study sites: 19 to 21v7
  9. Study sites: 17 to 19v6
  10. Site details revised at 3 of 17 sites
    • Eligibility criteria shortened, about 2 words
    v5
  11. Site details revised at 2 of 17 sitesv4
  12. Study sites: 2 to 17v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The Philadelphia chromosome negative myeloproliferative neoplasms (MPN) comprise a group of clonal hematological malignancies that are characterized by chronic myeloproliferation, splenomegaly, different degrees of bone marrow fibrosis, and disease-related symptoms including pruritus, night sweats, fever, weight loss, cachexia, and diarrhea. In addition, due to elevated numbers of leucocytes, erythrocytes and/or platelets, the disease course can be complicated by thromboembolic disease, hemorrhage, and leukemic transformation as well as myelofibrosis. Patients with polycythemia vera (PV) typically harbor an increased number of blood cells from all three hematopoietic cell lineages due to clonal amplification of hematopoetic stem cells, while patients with essential thrombocythemia (ET) typically show a predominant expansion of the megakaryocytic lineage. Most patients with PV below the age of 60 years are currently being treated with acetylsalicylic acid +/- phlebotomy only, and patients with low-risk ET have an almost normal life expectancy and often do not require specific treatment. However, PV- as well as ET-patients with a higher risk for complications require cytoreductive treatment. In addition, constitutional symptoms can be unbearable to patients even in the absence of bona fide high risk factors, and these patients may similarly benefit from antineoplastic therapy.
Trial Details
NCT Number NCT02577926
Lead Sponsor RWTH Aachen University
Collaborators: Novartis Pharmaceuticals
Conditions
(from sponsor)		 Polycythemia Vera (PV), Essential Thrombocythemia (ET)
Related terms Polycythemia Vera, Thrombocythemia, Essential
Enrollment 207 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov