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Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients

Study acronym: FIL_A-BEGEV
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Enrollment closed, study ongoing
    • Trial sites reduced: 32 → 28 locations
    • Primary completion moved earlier from Apr 27, 2027 to Dec 15, 2026
    • Study completion moved earlier from Apr 27, 2030 to Dec 15, 2029
    v10
  2. Minor Study sites: 22 to 32v9
  3. Minor Site details revised at 3 of 22 sitesv8
  4. Minor Study sites: 21 to 22v7
  5. Minor Site details revised at 7 of 21 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Primary completion date: May 8, 2025 to Apr 27, 2027v5 Show 6 more changesShow less
    • Start date: Aug 3, 2022 to Feb 27, 2023
    • Enrollment target: 140 to 122
    • Study sites: 20 to 21
    • Study completion date: Dec 8, 2028 to Apr 27, 2030
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 8 to 9
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 19 to 20
    • Start date changed from estimate of Dec 2022 to Aug 3, 2022
    v3
  4. Notable Start date: May 8, 2022 to Dec 2022v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The phase I part (safety assessment of the combination treatment) is aimed at determining the MTD of atezolizumab when combined with BEGEV schedule. 6-18 patients enrolled in this part will be treated with atezolizumab in combination with BEGEV regimen every 3 weeks for 4 cycles. Patients without a DLT in the first cycle and without disease progression after cycle 2, will undergo stem cell mobilization with 3-4 cycle of A-BEGEV + granulocyte colony-stimulating factor (G-CSF) and subsequently receive a myeloablative therapy followed by ASCT. The phase IIb part (expansion cohort) plans to randomize 122 patients in two arms (A and B, 61 per arm): 1. arm A will receive the BEGEV regimen followed by ASCT for patients achieving CR. 2. arm B will receive combination treatment with Atezolizumab and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks. After the last treatment date of the last patient (LPLT), the phase IIb will be ended. A long term follow up will start, in order to better assess patients' prognosis. All evaluable patients from phase I and phase IIb study will enter in the long term follow up phase and will be followed for 18 months.
Trial Details
NCT Number NCT05300282
Lead Sponsor Fondazione Italiana Linfomi - ETS
Collaborators: Roche Pharma AG
Conditions
(from sponsor)
Relapsed or Refractory Hodgkin's Lymphoma
Related terms Hodgkin Disease, Recurrence
Enrollment 122 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov