Comparison of High-Dose Chemotherapy + Rituximab and CHOP + Rituximab in High-Risk Follicular Lymphoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera San Giovanni Battista
• Collaborators: Gruppo Italiano Studio Linfomi; Gruppo Italiano Trapianto di Midollo Osseo; Hoffmann-La Roche; University of Turin, Italy
• Treatments: Rituximab

Criteria

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