Treatment Of Newly-diagnosed Follicular Lymphoma With CELMoD Golcadomide, Rituximab +/- Nivolumab.

Study acronym: TOP-FLOR
StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Jan 1, 2027 → Jan 1, 2028
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Record History

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  1. Primary completion pushed from Jan 1, 2027 to Jan 1, 2028 Show 4 more changesShow less
    • Study completion pushed from Jun 1, 2027 to Jun 1, 2029
    • Interventions: Nivolumab 10 MG/ML (Drug), Rituximab (Drug), golcadomide (Drug) to Nivolumab 10 MG/ML (Drug), Rituximab (Drug), golcadomide (Drug)
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 5 of 5 sites
    v10
  3. Re-verified, no change to tracked fieldsv9
  4. Site details revised at 1 of 5 sitesv8
  5. Primary endpoint revisedv7 Show 5 more changesShow less
    • Interventions: BMS-986369 (Drug), Nivolumab 10 MG/ML (Drug), Rituximab (Drug) to Nivolumab 10 MG/ML (Drug), Rituximab (Drug), golcadomide (Drug)
    • Study description revised
    • Site details revised at 2 of 5 sites
    • Study title revised
    • Eligibility criteria shortened, about 5 words
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 2 of 5 sitesv6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2023 to Aug 31, 2023
    • Site details revised at 5 of 5 sites
    v5
  3. Start date: Aug 1, 2023 to Sep 1, 2023v4
  4. 2 versions Re-verified since Apr 13, 2023, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • 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.
First line treatment with combination rituximab and golcadomide with, or without nivolumab, in patients in previously untreated Follicular Lymphoma
Trial Details
NCT Number NCT05788081
Lead Sponsor Olivia Newton-John Cancer Research Institute
Collaborators: Austin Health, Grampians Health, Fiona Stanley Hospital, Eastern Health, Barwon Health, Bristol-Myers Squibb
Conditions
(from sponsor)		 Follicular Lymphoma Stage II, Follicular Lymphoma Stage III, Follicular Lymphoma Stage IV
Related terms Lymphoma, Follicular
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov