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Efficacy and Safety of Carfilzomib in Combination With Ibrutinib vs Ibrutinib in Waldenström's Macroglobulinemia

Study acronym: CZAR-1
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 20 to 17
    • Primary and study completion dates: Aug 2028 to May 2028
    v10
  2. Start date: Feb 18, 2021 to Aug 18, 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Feb 2028 to Aug 2028
    • Site details revised at 20 of 20 sites
    v9
  3. Study sites revised (20)v8
  4. Phase: Phase 3 to Phase 2v7 Show 4 more changesShow less
    • Enrollment target: 184 to 99
    • Study sites: 17 to 20
    • Eligibility criteria expanded, about 56 words
    • Study description revised
  5. Study sites: 12 to 17
    • Study title expanded, about 4 words
    v6
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  1. Study sites: 8 to 12
    • Secondary endpoints: details revised at 1 of 11 entries
    v5
  2. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 8
    • Primary and study completion dates: Sep 2027 to Feb 2028
    • Start date changed from estimate of Jan 2021 to Feb 18, 2021
    • Secondary endpoints revised (11)
  3. Primary and study completion dates: Jun 2030 to Sep 2027v3 Show 4 more changesShow less
    • Start date: Jun 2020 to Jan 2021
    • Secondary endpoints: details revised at 7 of 11 entries
    • Study description revised
    • Collaborators: 4 to 2
  4. Study description expanded, about 2 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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) chemotherapy induces only low CR/VGPR (Complete Remission/ Very Good Partial Response) rates and responses of short duration compared to other indolent lymphomas. Thus, innovative approaches are needed which combine excellent activity and tolerability in WM. Chemotherapy-free approaches are highly attractive for this patient group. Based on its high activity in WM and its low toxicity, Ibrutinib was approved for the treatment of WM by the European Medicines Agency (EMA). However, also Ibrutinib fails to induce CRs and the VGPR rate is 16% in relapsed patients. In addition, activity of Ibrutinib depends on the genotype: compared to MYD88mut/CXCR4WT patients Ibrutinib single agent therapy induces substantially lower response rates in patients with the MYD88mut/CXCR4mut or the MYD88WT/CXCR4WT genotype (major response (at least PR) in 91.7 % compared to 61.9 and 0 %, respectively). Phase II data have indicated that the proteasome inhibitor Carfilzomib is able to overcome the inferior prognosis of Ibrutinib in MYD88mut/CXCR4mut and MYD88WT/CXCR4WT patients, as response rates were high for all genotypes in a phase II study combining Carfilzomib with Rituximab and Dexamethasone. Based on this the investigators hypothesize that addition of Carfilzomib to Ibrutinib will increase the VGPR/CR rate compared to Ibrutinib alone in patients with WM, in particular in patients carrying the CXCR4 mutation. In addition, the investigators hypothesize, that the combination Carfilzomib and Ibrutinib will be also highly active in MYD88 wildtype patients and that this combination will be at least as efficient in treatment naïve patients as in relapsed/refractory patients.
Trial Details
NCT Number NCT04263480
Lead Sponsor Christian Buske
Collaborators: Amgen, Janssen, LP
Conditions
(from sponsor)		 Waldenstrom Macroglobulinemia
Related terms Neoplasms, Waldenstrom Macroglobulinemia
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov