Status:
UNKNOWN
Comparison of High-Dose Chemotherapy + Rituximab and CHOP + Rituximab in High-Risk Follicular Lymphoma
Lead Sponsor:
Azienda Ospedaliera San Giovanni Battista
Collaborating Sponsors:
University of Turin, Italy
Gruppo Italiano Trapianto di Midollo Osseo
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 wi...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Follicular Lymphoma at diagnosis
- Stage \>I
- age-adjusted I.P.I. score 2 or 3 or three or more adverse factors of the I.L.I. score
Exclusion
- Serum positivity for HIV, HCV. HBsAg-positive only if active viral replication, assessed by HBV-DNA was present.
- Major alterations of heart, lung, kidneys, liver, except for those directly disease-related;
- Evidence of second tumors;
- Previous chemotherapy( except patients who received limited radiotherapy);
- Cerebral or CNS involvement.
- Drug addiction or severe psychiatric disease
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00435955
Start Date
March 1 2000
Last Update
February 16 2007
Active Locations (1)
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1
Divisione di Ematologia Universitaria
Torino, Italy, 10154