OncoMatch/Clinical Trials/NCT05300282
Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients
Is NCT05300282 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Atezolizumab and BEGEV for relapsed or refractory hodgkin's lymphoma.
Treatment: Atezolizumab · BEGEV — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — first-line
at first disease relapse or refractory to a first-line treatment or with documented persistent disease at interim positron emission tomography (PET) performed after 2 cycles of first line (ABVD/ABVD like/BEACOPP)
Cannot have received: allogeneic stem cell transplantation
Prior allogeneic stem cell transplantation
Cannot have received: solid organ transplant
prior solid organ transplant
Lab requirements
Blood counts
neutrophils ≥ 1,500/mmc; platelets ≥ 75,000/mmc; haemoglobin ≥ 8.0 g/dL with transfusion independence
Kidney function
creatinine clearance < 30 mL/min
Liver function
liver enzymes (AST/SGOT and/or ALT/SGPT) > 3 fold the upper limit of normal (except of liver involvement by lymphoma); total bilirubin > 1.5 mg/dL (except for patients with known Gilbert's disease or biliary tree compression by lymphoma masses)
Adequate haematological function, unless abnormalities due to underlying disease, at the moment of signing informed consent, defined as follows: neutrophils ≥ 1,500/mmc and platelets ≥ 75,000/mmc and haemoglobin ≥ 8.0 g/dL with transfusion independence. Any of the following laboratory abnormalities: liver enzymes (AST/SGOT and/or ALT/SGPT) > 3 fold the upper limit of normal (except of liver involvement by lymphoma); total bilirubin > 1.5 mg/dL (except for patients with known Gilbert's disease or biliary tree compression by lymphoma masses); creatinine clearance < 30 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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