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Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients.

Study acronym: FIL_DALYA
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 15 of 18 sitesv12
  2. Primary completion date: Jan 1, 2026 to Jul 1, 2027
    • Study completion date: Jun 1, 2027 to Jul 1, 2027
    • Study description revised
    v11
  3. Study completion date: Jan 1, 2026 to Jun 1, 2027
    • Site details revised at 13 of 18 sites
    v10
  4. Primary and study completion dates: Jan 1, 2025 to Jan 1, 2026
    • Site details revised at 12 of 18 sites
    v9
  5. Primary and study completion dates: Jun 1, 2024 to Jan 1, 2025
    • Site details revised at 2 of 18 sites
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Feb 1, 2024 to Jun 1, 2024v7
  2. Site details revised at 4 of 18 sitesv6
  3. Site details revised at 3 of 18 sitesv5
  4. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Jun 1, 2022 to Feb 1, 2024
    • Study completion date: Dec 1, 2023 to Jun 1, 2024
    • Start date changed from estimate of May 2022 to Jul 11, 2022
    • Site details revised at 18 of 18 sites
  5. Start date: Mar 18, 2021 to May 2022
    • Trial status: Active, Not Recruiting to Not Yet Recruiting
    • Site contacts updated at 9 of 18 sites
    v3
  6. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 19 to 18
    • Start date changed from estimate of Jun 1, 2021 to Mar 18, 2021
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
It is an open-label, multicenter, phase II, single arm trial to Evaluate Activity and Safety of Daratumumab in combination with Bortezomib and Dexamethasone in patients about 28 patients with Relapsed or Refractory Plasmablastic lymphoma.
Trial Details
NCT Number NCT04915248
Lead Sponsor Fondazione Italiana Linfomi - ETS
Collaborators: Janssen-Cilag S.p.A.
Conditions
(from sponsor)		 Plasmablastic Lymphoma
Related terms Lymphoma, Plasmablastic Lymphoma, Recurrence
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov