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Efficacy of First Line B-RI for Treatment Naive Waldenström's Macroglobulinemia

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Study completion date: Sep 2029 to Feb 2027v13
  2. Re-verified, no change to tracked fieldsv12
  3. Study sites: 15 to 12
    • Primary completion date changed from estimate of Dec 2022 to Nov 14, 2022
    • Collaborators revised (5)
    v11
  4. Primary completion date: Mar 2022 to Dec 2022v10
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 15 of 15 sites
    v9
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  1. Interventions: Ibrutinib (Drug) to Ibrutinib / Bortezomib / Rituximab (Drug)v8
  2. Study sites: 14 to 15
    • Eligibility criteria expanded, about 70 words
    • Secondary endpoints: 1 to 10
    v7
  3. Site details revised at 2 of 14 sitesv6
  4. Site details revised at 7 of 14 sites
    • Collaborators expanded, about 14 words
    v5
  5. Trial status: Not Yet Recruiting to Recruitingv4 Show 5 more changesShow less
    • Primary completion date: Nov 2020 to Mar 2022
    • Start date changed from estimate of Jun 1, 2019 to Sep 11, 2019
    • Study sites: 0 to 14
    • Study completion date: Nov 2024 to Sep 2029
    • Eligibility criteria revised
  6. Start date: Nov 2018 to Jun 1, 2019v3
  7. Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 18 words
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low complete remission (CR) rates and responses of short duration compared to other indolent lymphomas. Thus innovative approaches are needed which combine excellent activity and tolerability in patients with WM, who are mostly of advanced age. The immunochemotherapy DRC (dexamethasone, rituximab, cyclophosphamide) was shown to be highly effective in patients with WM without inducing major hematological toxicities. On the other hand the proteasome inhibitor bortezomib showed substantial activity as a single agent in WM with only very few side effects when given in a weekly schedule. Recent data confirmed high activity with low toxicity for ibrutinib in relapsed WM patients as single agent therapy. Based on these observations it is the aim of this study to investigate the efficacy and toxicity of the chemotherapy-free combination bortezomib, rituximab, ibrutinib (B-RI) in treatment naïve WM patient.
Trial Details
NCT Number NCT03620903
Lead Sponsor Christian Buske
Collaborators: University of Ulm, ClinAssess GmbH, Zentrum für Klinische Studien Ulm, Hoffmann-La Roche, Johnson & Johnson
Conditions
(from sponsor)		 Waldenstrom Macroglobulinemia
Related terms Waldenstrom Macroglobulinemia
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov