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Rituximab and Lenalidomide vs Rituximab Alone as Maintenance After R-chemoterapy for Relapsed/Refractory FL Patients

Study acronym: FIL_RENOIR12
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. 3 versions Re-verified since May 29, 2025, no change to tracked fieldsv16-v18
  2. Study completion date: Dec 2027 to Aug 2027v15
  3. Re-verified, no change to tracked fieldsv14
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 36 to 28
    • Primary completion date changed from estimate of Dec 2022 to Jan 25, 2023
    • Study completion date: Dec 2025 to Dec 2027
    v13
  5. Primary completion date: Jun 2022 to Dec 2022v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 35 to 36v11
  2. Primary completion date: Dec 2022 to Jun 2022
    • Site contacts updated at 2 of 35 sites
    v10
  3. Study sites revised (35)v9
  4. Site details revised at 1 of 35 sitesv8
  5. Site details revised at 24 of 35 sitesv7
  6. Primary completion date: Sep 2019 to Dec 2022
    • Study completion date: Mar 2022 to Dec 2025
    • Site contacts updated at 1 of 35 sites
    v6
  7. Site details revised at 1 of 35 sitesv5
  8. Study sites: 51 to 35v4
  9. Enrollment target: 253 to 128v3 Show 5 more changesShow less
    • Primary completion date: Nov 2018 to Sep 2019
    • Study completion date: May 2021 to Mar 2022
    • Eligibility criteria expanded, about 59 words
    • Site details revised at 2 of 51 sites
    • Study title revised
  10. Primary completion date: Jan 2017 to Nov 2018v2 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 27 to 51
    • Study completion date: Sep 2019 to May 2021
    • Start date: Apr 2014 to May 2014
    • Secondary endpoints revised (7)
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A randomized phase III multicenter trial assessing efficacy and toxicity of a combination of Rituximab and Lenalidomide (R2) vs Rituximab alone as maintenance after chemoimmunotherapy with Rituximab-chemotherapy (R-CHT) for relapsed/refractory FL patients not eligible for autologous transplantation (ASCT)
Trial Details
NCT Number NCT02390869
Lead Sponsor Fondazione Italiana Linfomi - ETS
Conditions
(from sponsor)		 Lymphoma, Follicular
Related terms Lymphoma, Follicular, Recurrence
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov