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

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT05300282
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Relapsed or Refractory Hodgkin's Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    In phase I study: Atezolizumab will be administered until the determination of its MTD when combined with BEGEV schedule. In phase II b study - arm A (standard): Atezolizumab will not be administered. In phase II b study - arm B (experimental): Atezolizumab will be administered at MTD determined in phase I study plus BEGEV regimen (at dosages performed by local practice).
  • BEGEV — COMBINATION_PRODUCT
    In phase I study: Atezolizumab will be administered until the determination of its MTD when combined with BEGEV schedule. In phase II b study - arm A (standard): only BEGEV will be administered. In phase II b study - arm B (experimental): BEGEV regimen will be administered in combination with Atezolizumab at MTD determined in phase I.

Study Details

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.

Key Dates

Start date
Feb 27, 2023
Status verified
Jan 2026
Primary completion
Apr 27, 2027
Completion
Apr 27, 2030

Study Design

Enrollment
122 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: phase I
    patients will receive the BEGEV regimen plus Atezolizumab in order to determine MTD of the last one drug.
  • Active Comparator: phase IIb - arm A
    patients will receive the BEGEV regimen followed by ASCT for patients achieving CR.
  • Experimental: phase IIb - arm B
    patients will receive combination treatment with Atezolizumab (at dose obtained from phase I) and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks.

Primary Outcome Measure

For Phase I part: evaluation of the maximum tolerated dose (MTD) of the atezolizumab. [ Time Frame: During first cycle of treatment based on atezolizumab in combination with BEGEV in phase I study. Maximum time frame 17 months. ]

Central Contacts