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Shortened vs Standard Chemotherapy Combined With Immunotherapy for the Initial Treatment of Patients With High Tumor Burden Follicular Lymphoma

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 71 to 54v9
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 602 to confirmed 605
    • Site details revised at 71 of 71 sites
    v8
  3. Site details revised at 1 of 71 sitesv7
  4. Site details revised at 10 of 71 sitesv6
  5. Study sites: 66 to 71v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 69 to 66v4
  2. Site details revised at 15 of 69 sitesv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2021 to Dec 1, 2021
    • Site details revised at 69 of 69 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
FIL\_FOLL19 is an open-label, multicenter, randomized phase III trial. The sponsor of this clinical trial is Fondazione Italiana Linfomi (FIL). The Primary Objective of the study is to demonstrate that, in patients with newly diagnosed, advanced stage Follicular Lymphoma (FL) with high tumor burden according to the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria, a treatment strategy that reduces the number of chemotherapy cycles in case of early response to immunochemotherapy is not inferior compared to standard therapy at full dose in terms of Progression-Free Survival (PFS).
Trial Details
NCT Number NCT05058404
Lead Sponsor Fondazione Italiana Linfomi - ETS
Conditions
(from sponsor)		 Follicular Lymphoma
Related terms Lymphoma, Follicular
Enrollment 605 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov