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Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients

Study acronym: RITZ
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 50 to 49v22
  2. Study sites: 51 to 50v21
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 120 to confirmed 122
    • Study sites: 55 to 51
    v20
  4. Study sites: 56 to 55v19
  5. Study sites: 55 to 56v18
Show 16 earlier versionsHide 16 earlier versions
  1. Site details revised at 4 of 55 sitesv17
  2. Site details revised at 3 of 55 sitesv16
  3. Site details revised at 1 of 55 sitesv15
  4. Site details revised at 4 of 55 sites
    • Eligibility criteria shortened, about 1 word
    v14
  5. Site details revised at 1 of 55 sitesv13
  6. Site details revised at 5 of 55 sitesv12
  7. Study sites revised (55)v11
  8. Site details revised at 1 of 55 sitesv10
  9. Site details revised at 5 of 55 sitesv9
  10. Site details revised at 4 of 55 sitesv8
  11. Study sites: 54 to 55v7
  12. Study sites: 39 to 54v6
  13. Site details revised at 6 of 39 sitesv5
  14. Start date changed from estimate of May 2024 to May 21, 2024
    • Site details revised at 7 of 39 sites
    v4
  15. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2024 to May 2024
    • Study sites: 5 to 39
    • Primary and study completion dates: Feb 2029 to May 2029
    v3
  16. Start date: Sep 2023 to Feb 2024
    • Primary and study completion dates: Sep 2028 to Feb 2029
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to compare the efficacy and tolerability of the combination of two medicinal products, rituximab, and zanubrutinib, compared to rituximab monotherapy in patients with Splenic Marginal Zone Lymphoma (SMZL), previously untreated and who need systemic treatment. The main questions it aims to answer are: * Is the combination rituximab and zanubrutinib a more effective therapy than rituximab monotherapy? * Is the combination therapy, rituximab and zanubrutinib, well tolerated? Study participants will be put into one of the two treatment groups (rituximab and zanubrutinib or rituximab alone) for a maximum of two years and will undergo regular visits until three years from treatment start.
Trial Details
NCT Number NCT05735834
Lead Sponsor International Extranodal Lymphoma Study Group (IELSG)
Conditions
(from sponsor)		 Splenic Marginal Zone Lymphoma
Enrollment 122 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov