A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)

Exclusion Criteria

• •Signed informed written consent
• •Grade IIIb FL, transformed FL or histologies different from FL
• •Previous treatment with \> two lines of chemotherapy ± rituximab Maintenance is UNOTU considered a therapeutics line)
• •Previous ASCT or RIT treatment
• •CNS involvement by lymphoma
• •HBV positivity with the exception of patients who are seropositive because of hepatitis B virus vaccination and patients HbcAb positive and HbsAg negative with undetectable serum HBV-DNA. Occult carriers: must receive treatment with Lamivudine 100 mg for the duration of treatment program and at least 12 months after treatment cessation; HBV-DNA levels and HBsAg will be monitored every month
• •HCV positivity with elevated transaminases or INR or APTT or active virus replication
• •HIV positivity
• •Any concurrent medical condition requiring long term use (\> one month) of systemic corticosteroids
• •Active bacterial, viral, or fungal infection requiring systemic therapy
• •Any concurrent medical or psychiatric condition which might impair administration of therapy or preclude the ability to give informed consent
• •Treatment with an experimental agent within 30 days prior to study entry
• •Myelosuppressive chemo or biological therapy within three weeks before study entry (use rituximab course delivered as maintenance is not an exclusion therapy)
• •Major surgery other than diagnosis within 4 weeks prior to study entry
• •Previous i.v. or i.m. treatments with murine or animal derived antibodies