MULTICENTER RANDOMIZED PROGRAM COMPARING HIGH-DOSE CHEMOTHERAPY + RITUXIMAB AND PERIPHERAL BLOOD PROGENITOR CELL (PBPC) AUTOGRAFT vs. CHOP + RITUXIMAB AS FIRST-LINE TREATMENT FOR PATIENTS WITH HIGH-RISK FOLLICULAR LYMPHOMA
The place of intensified regimens with autologous stem cell transplantation (ASCT) is poorly
defined in FL at diagnosis . Most data arise from studies performed in the pre-Rituximab
age. According to these studies, ASCT improved overall survival versus standard salvage
approaches in relapsed patients with a high proportion of patients achieving a durable
molecular remission. Data at diagnosis are less clear. Three studies have been so far
published with contradictory results. Two of these studies showed that intensive therapy
ensures a better disease control although in one study a significant extra-mortality from
secondary tumors was observed in the intensified arm. A third study found no advantage for
patients treated intensively. These results led to the widespread notion that ASCT is not
superior to conventional chemotherapy in unselected FL patients. Our previous non-randomized
experience employing high dose sequential chemotherapy with a final TBI-free ASCT added some
clues to these considerations. Our study employs an autografting procedure which is
associated to fewer secondary tumors as it does not include total body irradiation. Moreover
we have observed that the our regimen (named HDS) is particularly effective in high-risk
patients, suggesting that this specific subgroup is the most appropriate setting for
intensified regimens
The present multicenter open label randomized trial took advantage of these observations. In
addition we have included Rituximab in both arms as the inclusion of this novel agent is
expected to significantly modify the performance of available treatments. We have thus
compared a Rituximab-supplemented version of HDS (R-HDS) regimen with six CHOP courses
supplemented by an identical number of Rituximab courses. Aim of the study was verify if an
intensified approach could be beneficial as first line treatment of high-risk FL patients in
the Rituximab age.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Event free survival at three years
Corrado Tarella, MD
Principal Investigator
Università di Torino, Azienda Ospedaliera San Giovanni Battista
Italy: Ministry of Health
3320
NCT00435955
March 2000
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