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Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy

Study acronym: FIL_Tisle-HL
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Nov 2027 → Nov 2028
See other at-risk trials from Fondazione Italiana Linfomi - ETS

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Nov 2027 to Nov 2028
    • Study completion pushed from Nov 2029 to Nov 2030
    • Study sites: 10 to 12
    v8
  2. Minor Site details revised at 1 of 10 sitesv7
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Notable Primary completion date: Apr 2027 to Nov 2027
    • Study completion date: Apr 2029 to Nov 2029
    • Site details revised at 2 of 10 sites
    v5
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2023 to May 23, 2024
    • Site details revised at 10 of 10 sites
    v4
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  1. Notable Start date: Oct 2023 to Dec 2023
    • Enrollment target: 25 to 28
    • Eligibility criteria shortened, about 167 words
    • Secondary endpoints revised (5)
    v3
  2. Minor Study title shortened, about 5 wordsv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, prospective, non-randomized, open-label, phase 2 clinical study to evaluate the efficacy and safety of tislelizumab in patients with de novo Hodgkin Lymphoma deemed ineligible to frontline chemotherapy.
Trial Details
NCT Number NCT05977673
Lead Sponsor Fondazione Italiana Linfomi - ETS
Conditions
(from sponsor)
Hodgkin Lymphoma
Related terms Hodgkin Disease, Lymphoma
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov