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Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients.

Study acronym: FIL_COLUMN
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Mar 21, 2026 → Mar 2027
See other at-risk trials from Fondazione Italiana Linfomi - ETS

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 21, 2026 to Mar 2027
    • Enrollment closed, study ongoing
    • Study sites: 21 to 19
    v11
  2. Primary completion date: Mar 2026 to Mar 21, 2026
    • Site details revised at 1 of 21 sites
    v10
  3. Primary completion date: Apr 2026 to Mar 2026
    • Study completion date: Apr 2029 to Mar 2029
    • Start date: Apr 21, 2022 to Mar 21, 2022
    v9
  4. Re-verified, no change to tracked fieldsv8
  5. Primary completion date: Feb 2025 to Apr 2026v7 Show 5 more changesShow less
    • Enrollment target: 56 to 49
    • Study completion date: Feb 2027 to Apr 2029
    • Eligibility criteria revised
    • Study description expanded, about 12 words
    • Site details revised at 9 of 21 sites
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 3 of 21 sitesv6
  2. Interventions: Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy (R-BAC, Rituximab - Bendamustine, Ara-C)) (Drug) to Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at reduced dose (R-BAC, Rituximab - Bendamustine…v5
  3. Eligibility criteria shortened, about 121 words
    • Study description expanded, about 81 words
    • Site details revised at 17 of 21 sites
    v4
  4. Study sites: 20 to 21v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2022 to Apr 21, 2022
    • Site details revised at 20 of 20 sites
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective, phase 2, multicenter, open-label, single-arm study. Primary objective is to assess the efficacy of loncastuximab tesirine given as consolidation therapy after salvage immunochemotherapy in BTKi (Bruton Tyrosine Kinase inhibitors) -treated (or BTKi intolerant) R/R (Relapse or Refractory) MCL (Mantle Cell Lymphoma) patients. The sponsor of this clinical trial is Fondazione Italiana Linfomi - ETS (FIL ETS).
Trial Details
NCT Number NCT05249959
Lead Sponsor Fondazione Italiana Linfomi - ETS
Conditions
(from sponsor)		 Relapsed Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma
Related terms Lymphoma, Mantle-Cell
Enrollment 49 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov