All patients will receive a 15-minute intravenous (IV) infusion with TAG on days 4-6 of each 28-day cycle. VEN will be taken orally on days 1-14 of each 28-day cycle. SOC therapy will be administered throughout the study. After 3 treatment cycles, during cycle 4, response assessment will be performed on all patients. Non-responding patients will discontinue treatment after completion of V8, undergo EOT and enter the follow-up stage of the trial. Responding patients will continue treatment for further 8 cycles after V8 (i.e., a max. of 12 treatment cycles, which is believed to be sufficient to maintain durable remission) or until loss of responses/disease progression.
All patients will receive a 15-minute intravenous (IV) infusion with TAG on days 4-6 of each 28-day cycle. VEN will be taken orally on days 1-14 of each 28-day cycle. SOC therapy will be administered throughout the study. After 3 treatment cycles, during cycle 4, response assessment will be performed on all patients. Non-responding patients will discontinue treatment after completion of V8, undergo EOT and enter the follow-up stage of the trial. Responding patients will continue treatment for further 8 cycles after V8 (i.e., a max. of 12 treatment cycles, which is believed to be sufficient to maintain durable remission) or until loss of responses/disease progression.
