Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients
Status:
Not yet recruiting
Trial end date:
2028-12-08
Target enrollment:
Participant gender:
Summary
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.