A Study of Atezolizumab and BEGEV Regimen as First Salvage Treatment for Adults with Relapsed or Refractory Hodgkins Lymphoma Undergoing Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining atezolizumab with the BEGEV regimen as a first salvage treatment for patients with relapsed or refractory Hodgkins lymphoma who are candidates for autologous stem-cell transplantation ASCT. This study includes a phase I part to find the maximum tolerated dose MTD of atezolizumab when combined with BEGEV, and a phase IIb part to compare treatments with or without atezolizumab in a larger group of patients. The goal is to improve treatment responses and patient prognosis through this combined approach. In the phase I part, 6 to 18 patients will receive atezolizumab combined with the BEGEV regimen every 3 weeks for 4 cycles to determine the MTD. Patients without dose-limiting toxicity or disease progression will undergo stem cell mobilization with additional cycles of A-BEGEV and granulocyte colony-stimulating factor G-CSF, followed by myeloablative therapy and ASCT. In phase IIb, 122 patients will be randomized into two arms one receiving BEGEV alone followed by ASCT, and the other receiving atezolizumab plus BEGEV followed by ASCT and consolidation with six doses of atezolizumab every 4 weeks. Radiotherapy may also be planned based on clinical judgment. Participants will be monitored throughout the induction, consolidation, and follow-up phases for treatment response, safety, and side effects. Assessments include evaluating complete response rate before ASCT, overall response rates, stem cell mobilization, engraftment after ASCT, duration of response, progression-free survival, and overall survival. After the last treatment, all patients will enter a long-term follow-up for 18 months to track disease status, survival, secondary cancers, and late toxicities, with evaluations every 6 months until withdrawal, loss to follow-up, or death.

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