This is a phase Ib/II (dose escalation/dose expansion), single-arm multi-centre clinical trial of venetoclax plus obinutuzumab and lenalinomide in patients with treatment-naïve follicular lymphoma. The trial involves an initial dose escalation phase followed by an expansion phase. Patients in both the dose escalation and expansion phases will receive 6 cycles of induction treatment. After patients finish induction treatment, they will undergo PET-CT scan, the results of which will determine further therapy. Patients in CR or SD/PR from the PET-CT scan result will receive up to 2 years of maintenance therapy. Patients in PD from the PET-CT result will not receive any further study treatment. All patients will be followed up for 3 years after the last patient has completed induction treatment.
The trial will investigate the combination of venetoclax, obinutuzumab and lenalidomide in patients with treatment-naïve follicular lymphoma. Patients will receive induction treatment for 0.5 years with venetoclax, obinutuzumab and lenalidomide followed by maintenance treatment for upto 2 years. Maintenance treatment will be determined by the response at the end of induction. Following completion of treatment patients will be followed up for 3 years after the last patient completes induction treatment.