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

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase III, multicenter, open-label, randomized and controlled study to compare the efficacy of a consolidation therapy with RIT versus ASCT in patients with FL in CR or PR after second or third line chemotherapy supplemented with rituximab.

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

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Age 18-65

• Histologically documented diagnosis of grade I-IIIa FL defined according to WHO guidelines 2008 (Re-biopsy required)

• Availability of BM and PB for Minimal Residual Disease (MRD) analysis (see Appendix I)

• Relapsed or refractory disease after ≤ two chemotherapy lines at least one containing Rituximab (Rituximab maintenance is UNOTU considered a therapeutic line)

• Clinical indication of treatment i.e. Stage II-IV who require therapy according to SIE and GELF criteria (see Appendix II)

• ECOG performance status 0-2 (unless disease-related) (see Appendix III)

• Availability of histological material for centralized revision

• Laboratory values:

• ANC ≥ 1500/mmc unless due to marrow involvement by lymphoma and/or platelets ≥ 100000/mmc unless due to marrow involvement by lymphoma

• Serum creatinine ≤ 1.5 x ULN, unless it is disease related

• Bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN, if patient has Gilbert syndrome)

• AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN if not lymphoma related or ≤ 5.0 x ULN in case of lymphoma liver involvement

• Adequate cardiac function: LVEF > 50% by echocardiography or MUGA scan

• Not pregnant or breast-feeding

• Willingness to use effective contraception during the study and 3 months after the end of treatment

• No other prior malignancies except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for ≥ 5 years (see Exclusion criteria 14)

• Signed informed written consent

Exclusion Criteria:

• 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