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MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas

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

Record History

See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Jan 14, 2026, no change to tracked fieldsv20-v21
  2. Primary completion date: Jun 15, 2024 to Jun 15, 2027
    • Study sites: 37 to 36
    v19
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 37 of 37 sites
    v18
  4. 2 versions Re-verified since May 3, 2022, no change to tracked fieldsv16-v17
  5. Study sites: 36 to 37v15
Show 13 earlier versionsHide 13 earlier versions
  1. Site details revised at 1 of 36 sitesv14
  2. Site details revised at 1 of 36 sitesv13
  3. Enrollment target: 160 to 175
    • Eligibility criteria expanded, about 14 words
    • Site details revised at 8 of 36 sites
    v12
  4. Site details revised at 4 of 36 sites
    • Eligibility criteria expanded, about 3 words
    v11
  5. Eligibility criteria expanded, about 85 words
    • Site details revised at 3 of 36 sites
    v10
  6. Study sites: 32 to 36v9
  7. Re-verified, no change to tracked fieldsv8
  8. Site details revised at 5 of 32 sitesv7
  9. Site details revised at 3 of 32 sitesv6
  10. Site details revised at 2 of 32 sitesv5
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 18 to 32
    • Start date changed from estimate of Sep 15, 2019 to Sep 27, 2019
    • Eligibility criteria expanded, about 89 words
    v4
  12. Start date: Jun 15, 2019 to Sep 15, 2019v3
  13. Start date: Apr 15, 2019 to Jun 15, 2019v2 Show 4 more changesShow less
    • Study sites: 3 to 18
    • Primary completion date: Apr 15, 2024 to Jun 15, 2024
    • Study completion date: Apr 15, 2027 to Jun 15, 2027
    • Secondary endpoints revised (4)
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Single-arm, phase II clinical trial of patients with Extranodal Marginal Zone Lymphoma (EMZL). It is planned to recruit 130 patients. Additional patients with Splenic Marginal Zone Lymphoma (SMZL), up to 30, and Nodal Marginal Zone Lymphoma (NMZL), up to 15, will be included in the trial in order to preliminary explore the clinical activity and safety of the combination treatment proposed. The study primary endpoints will be analysed on the EMZL population. Outcome of patients with SMZL and NMZL will be analysed and reported separately
Trial Details
NCT Number NCT03697512
Lead Sponsor International Extranodal Lymphoma Study Group (IELSG)
Conditions
(from sponsor)		 Marginal Zone Lymphoma, Nodal Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma
Related terms Lymphoma, B-Cell, Marginal Zone
Enrollment 175 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov