Overview

This trial is active, not recruiting.

Condition follicular lymphoma
Treatments high dose chemotherapy with autologous transplantation, rituximab
Phase phase 3
Target CD20
Sponsor Azienda Ospedaliera San Giovanni Battista
Collaborator University of Turin, Italy
Start date March 2000
Trial size 240 participants
Trial identifier NCT00435955, 3320

Summary

The purpose of this study is to determine whether an intensified treatment plus Rituximab followed by autologous transplantation is superior to a conventional chemotherapy regimen also supplemented with Rituximab.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Event free survival at three years
time frame:

Secondary Outcomes

Measure
Overall survival
time frame:
CR rate
time frame:
Progression free survival
time frame:
Disease free survival I
time frame:
Incidence of secondary myelodisplasia and solid cancer
time frame:
Rate of molecular remission
time frame:
Predictive value of molecular remission
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: 1. Follicular Lymphoma at diagnosis 2. Stage >I 3. age-adjusted I.P.I. score 2 or 3 or three or more adverse factors of the I.L.I. score Exclusion Criteria: 1. Serum positivity for HIV, HCV. HBsAg-positive only if active viral replication, assessed by HBV-DNA was present. 2. Major alterations of heart, lung, kidneys, liver, except for those directly disease-related; 3. Evidence of second tumors; 4. Previous chemotherapy( except patients who received limited radiotherapy); 5. Cerebral or CNS involvement. 6. Drug addiction or severe psychiatric disease

Additional Information

Official title 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
Principal investigator Corrado Tarella, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2007.
Information provided to ClinicalTrials.gov by Azienda Ospedaliera San Giovanni Battista.